Trial Outcomes & Findings for Neuroendocrine Risk for PTSD in Women (NCT NCT03973229)
NCT ID: NCT03973229
Last Updated: 2026-07-22
Results Overview
Responses to threat cues are assessed by functional magnetic resonance imaging (fMRI) responses as participants view 15 blocks each of fearful face and neutral face stimuli, while amygdala reactivity is measured. The amygdala is separated in the right and left hemispheres, and subdivided into the basolateral amygdala and central amygdala. Across voxels in each region a contrast estimate of Fearful \> Neutral faces was extracted. The contrast estimate is a standard reporting format for task-based fMRI data, and reflects the magnitude of blood oxygen level dependent (BOLD) activation difference between two experimental conditions. Contrast estimates are an arbitrary, unitless comparison of fMRI BOLD signal units of one experimental condition versus another (threat vs. neutral stimuli). Higher values indicate greater amygdala reactivity to threat cues (vs. neutral cues), a PTSD-linked response pattern. Negative values indicate stronger amygdala reactivity to neutral cues than threat cues.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
127 participants
Primary outcome timeframe
Early-cycle for Cohort 1 (mean 4.5 (sd=1.5) days following onset of menstrual period) or Mid-cycle for cohort 2 (mean 5.5 (sd=1.4) days following a positive urine luteinizing hormone test) during cycles 2 and 3 (each cycle is an average of 28 days)
Results posted on
2026-07-22
Participant Flow
Participants were recruited from Grady Memorial Hospital clinics in Atlanta, Georgia, USA. Participant enrollment began November 11, 2019 and the final study assessment occurred on April 30, 2025.
Participant milestones
| Measure |
Cohort 1: PTSD Receiving Estradiol Then Placebo
Participants with PTSD record their first cycle with the Clue app. They receive the estradiol patch during the second cycle, and the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 1: PTSD Receiving Placebo Then Estradiol
Participants with PTSD record their first cycle with the Clue app. They receive the placebo patch during the second cycle, and the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 1: Trauma Without PTSD Receiving Estradiol Then Placebo
Participants with trauma exposure record their first cycle with the Clue app. They receive the estradiol patch during the second cycle, and the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 1: Trauma Without PTSD Receiving Placebo Then Estradiol
Participants with trauma exposure record their first cycle with the Clue app. They receive the placebo patch during the second cycle, and the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 1: Healthy Controls Receiving Estradiol Then Placebo
Participants without trauma history or psychiatric disorder record their first cycle with the Clue app. They receive the estradiol patch during the second cycle, and the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 1: Healthy Controls Receiving Placebo Then Estradiol
Participants without trauma history or psychiatric disorder record their first cycle with the Clue app. They receive the placebo patch during the second cycle, and the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: PTSD Receiving Estradiol Then Placebo
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the estradiol patch before getting the MRI. They apply the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: PTSD Receiving Placebo Then Estradiol
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the placebo patch before getting the MRI. They apply the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: Trauma Control Receiving Estradiol, Then Placebo
Participants with trauma exposure begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the estradiol patch before getting the MRI. They apply the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug is applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: Trauma Control Receiving Placebo Then Estradiol
Participants with trauma exposure begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the placebo patch before getting the MRI. They apply the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: Healthy Control Receiving Estradiol Then Placebo
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the estradiol patch before getting the MRI. They apply the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: Healthy Control Receiving Placebo Then Estradiol
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the placebo patch before getting the MRI. They apply the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
First Treatment Condition
STARTED
|
15
|
7
|
10
|
14
|
10
|
12
|
9
|
10
|
12
|
10
|
7
|
11
|
|
First Treatment Condition
COMPLETED
|
14
|
7
|
10
|
14
|
9
|
11
|
8
|
8
|
10
|
6
|
7
|
11
|
|
First Treatment Condition
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
1
|
1
|
2
|
2
|
4
|
0
|
0
|
|
Second Treatment Condition
STARTED
|
12
|
6
|
7
|
12
|
9
|
10
|
8
|
5
|
9
|
6
|
5
|
11
|
|
Second Treatment Condition
COMPLETED
|
12
|
6
|
7
|
12
|
9
|
10
|
8
|
5
|
9
|
6
|
5
|
11
|
|
Second Treatment Condition
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: PTSD Receiving Estradiol Then Placebo
Participants with PTSD record their first cycle with the Clue app. They receive the estradiol patch during the second cycle, and the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 1: PTSD Receiving Placebo Then Estradiol
Participants with PTSD record their first cycle with the Clue app. They receive the placebo patch during the second cycle, and the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 1: Trauma Without PTSD Receiving Estradiol Then Placebo
Participants with trauma exposure record their first cycle with the Clue app. They receive the estradiol patch during the second cycle, and the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 1: Trauma Without PTSD Receiving Placebo Then Estradiol
Participants with trauma exposure record their first cycle with the Clue app. They receive the placebo patch during the second cycle, and the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 1: Healthy Controls Receiving Estradiol Then Placebo
Participants without trauma history or psychiatric disorder record their first cycle with the Clue app. They receive the estradiol patch during the second cycle, and the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 1: Healthy Controls Receiving Placebo Then Estradiol
Participants without trauma history or psychiatric disorder record their first cycle with the Clue app. They receive the placebo patch during the second cycle, and the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: PTSD Receiving Estradiol Then Placebo
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the estradiol patch before getting the MRI. They apply the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: PTSD Receiving Placebo Then Estradiol
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the placebo patch before getting the MRI. They apply the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: Trauma Control Receiving Estradiol, Then Placebo
Participants with trauma exposure begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the estradiol patch before getting the MRI. They apply the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug is applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: Trauma Control Receiving Placebo Then Estradiol
Participants with trauma exposure begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the placebo patch before getting the MRI. They apply the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: Healthy Control Receiving Estradiol Then Placebo
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the estradiol patch before getting the MRI. They apply the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: Healthy Control Receiving Placebo Then Estradiol
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the placebo patch before getting the MRI. They apply the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
First Treatment Condition
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
|
First Treatment Condition
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
2
|
0
|
0
|
|
First Treatment Condition
New exclusion criteria identified
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Neuroendocrine Risk for PTSD in Women
Baseline characteristics by cohort
| Measure |
Cohort 1: PTSD Receiving Estradiol Then Placebo
n=15 Participants
Participants with PTSD record their first cycle with the Clue app. They receive the estradiol patch during the second cycle, and the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 1: PTSD Receiving Placebo Then Estradiol
n=7 Participants
Participants with PTSD record their first cycle with the Clue app. They receive the placebo patch during the second cycle, and the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 1: Trauma Without PTSD Receiving Estradiol Then Placebo
n=10 Participants
Participants with trauma exposure record their first cycle with the Clue app. They receive the estradiol patch during the second cycle, and the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 1: Trauma Without PTSD Receiving Placebo Then Estradiol
n=14 Participants
Participants with trauma exposure record their first cycle with the Clue app. They receive the placebo patch during the second cycle, and the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 1: Healthy Controls Receiving Estradiol Then Placebo
n=10 Participants
Participants without trauma history or psychiatric disorder record their first cycle with the Clue app. They receive the estradiol patch during the second cycle, and the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 1: Healthy Controls Receiving Placebo Then Estradiol
n=12 Participants
Participants without trauma history or psychiatric disorder record their first cycle with the Clue app. They receive the placebo patch during the second cycle, and the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: PTSD Receiving Estradiol Then Placebo
n=9 Participants
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the estradiol patch before getting the MRI. They apply the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: PTSD Receiving Placebo Then Estradiol
n=10 Participants
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the placebo patch before getting the MRI. They apply the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: Trauma Control Receiving Estradiol, Then Placebo
n=12 Participants
Participants with trauma exposure begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the estradiol patch before getting the MRI. They apply the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug is applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: Trauma Control Receiving Placebo Then Estradiol
n=10 Participants
Participants with trauma exposure begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the placebo patch before getting the MRI. They apply the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: Healthy Control Receiving Estradiol Then Placebo
n=7 Participants
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the estradiol patch before getting the MRI. They apply the placebo patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Cohort 2: Healthy Control Receiving Placebo Then Estradiol
n=11 Participants
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During the second month of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase) and they use the placebo patch before getting the MRI. They apply the estradiol patch during the third cycle.
Estradiol patch: Estradiol (E2) patches at a dose of 100ug are applied 24-48 hours before the MRI scan is performed.
Placebo patch: Placebo patch identical to the estradiol patch is applied 24-48 hours before the MRI scan is performed.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
26.3 years
STANDARD_DEVIATION 4.8 • n=9 Participants
|
25.7 years
STANDARD_DEVIATION 3.8 • n=27 Participants
|
25.7 years
STANDARD_DEVIATION 5.2 • n=267 Participants
|
26.3 years
STANDARD_DEVIATION 4.9 • n=265 Participants
|
23.6 years
STANDARD_DEVIATION 4.9 • n=568 Participants
|
26.4 years
STANDARD_DEVIATION 4.5 • n=22 Participants
|
24.4 years
STANDARD_DEVIATION 4.9 • n=23 Participants
|
27.8 years
STANDARD_DEVIATION 6.8 • n=22 Participants
|
27.3 years
STANDARD_DEVIATION 6.4 • n=178 Participants
|
25.9 years
STANDARD_DEVIATION 5.3 • n=116 Participants
|
23.4 years
STANDARD_DEVIATION 5.9 • n=2 Participants
|
24.6 years
STANDARD_DEVIATION 3.9 • n=4 Participants
|
25.7 years
STANDARD_DEVIATION 5.1 • n=190 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
14 Participants
n=265 Participants
|
10 Participants
n=568 Participants
|
12 Participants
n=22 Participants
|
9 Participants
n=23 Participants
|
10 Participants
n=22 Participants
|
12 Participants
n=178 Participants
|
10 Participants
n=116 Participants
|
7 Participants
n=2 Participants
|
11 Participants
n=4 Participants
|
127 Participants
n=190 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=190 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
13 Participants
n=265 Participants
|
10 Participants
n=568 Participants
|
11 Participants
n=22 Participants
|
9 Participants
n=23 Participants
|
10 Participants
n=22 Participants
|
12 Participants
n=178 Participants
|
10 Participants
n=116 Participants
|
7 Participants
n=2 Participants
|
11 Participants
n=4 Participants
|
124 Participants
n=190 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
14 Participants
n=265 Participants
|
10 Participants
n=568 Participants
|
12 Participants
n=22 Participants
|
9 Participants
n=23 Participants
|
10 Participants
n=22 Participants
|
12 Participants
n=178 Participants
|
10 Participants
n=116 Participants
|
7 Participants
n=2 Participants
|
11 Participants
n=4 Participants
|
127 Participants
n=190 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
14 Participants
n=265 Participants
|
10 Participants
n=568 Participants
|
12 Participants
n=22 Participants
|
9 Participants
n=23 Participants
|
10 Participants
n=22 Participants
|
12 Participants
n=178 Participants
|
10 Participants
n=116 Participants
|
7 Participants
n=2 Participants
|
11 Participants
n=4 Participants
|
127 Participants
n=190 Participants
|
PRIMARY outcome
Timeframe: Early-cycle for Cohort 1 (mean 4.5 (sd=1.5) days following onset of menstrual period) or Mid-cycle for cohort 2 (mean 5.5 (sd=1.4) days following a positive urine luteinizing hormone test) during cycles 2 and 3 (each cycle is an average of 28 days)Population: Cohort 1 was examined during the early-cycle, while Cohort 2 was examined mid-cycle.
Responses to threat cues are assessed by functional magnetic resonance imaging (fMRI) responses as participants view 15 blocks each of fearful face and neutral face stimuli, while amygdala reactivity is measured. The amygdala is separated in the right and left hemispheres, and subdivided into the basolateral amygdala and central amygdala. Across voxels in each region a contrast estimate of Fearful \> Neutral faces was extracted. The contrast estimate is a standard reporting format for task-based fMRI data, and reflects the magnitude of blood oxygen level dependent (BOLD) activation difference between two experimental conditions. Contrast estimates are an arbitrary, unitless comparison of fMRI BOLD signal units of one experimental condition versus another (threat vs. neutral stimuli). Higher values indicate greater amygdala reactivity to threat cues (vs. neutral cues), a PTSD-linked response pattern. Negative values indicate stronger amygdala reactivity to neutral cues than threat cues.
Outcome measures
| Measure |
Cohort 1: PTSD Receiving Placebo
n=17 Participants
Participants with PTSD during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 1: PTSD Receiving Estradiol
n=19 Participants
Participants with PTSD during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Trauma Control Receiving Estradiol
n=21 Participants
Participants with trauma exposure without PTSD during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Trauma Control Receiving Placebo
n=21 Participants
Participants with trauma exposure without PTSD during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 1: Healthy Controls Receiving Estradiol
n=18 Participants
Participants without trauma history or psychiatric disorder during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Healthy Controls Receiving Placebo
n=19 Participants
Participants without trauma history or psychiatric disorder during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 2: PTSD Receiving Estradiol
n=12 Participants
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: PTSD Receiving Placebo
n=14 Participants
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
Cohort 2: Trauma Control Receiving Estradiol
n=16 Participants
Participants with trauma exposure without PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: Trauma Control Receiving Placebo
n=15 Participants
Participants with trauma exposure without PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
Cohort 2: Healthy Control Receiving Estradiol
n=17 Participants
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: Healthy Control Receiving Placebo
n=15 Participants
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Amygdala Response to Fearful Faces Stimuli
Early-cycle: Left basolateral amygdala
|
0.00 arbitrary units
Standard Deviation 0.11
|
0.03 arbitrary units
Standard Deviation 0.15
|
0.03 arbitrary units
Standard Deviation .012
|
0.06 arbitrary units
Standard Deviation 0.11
|
-0.01 arbitrary units
Standard Deviation 0.07
|
0.01 arbitrary units
Standard Deviation 0.14
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amygdala Response to Fearful Faces Stimuli
Early-cycle: Right basolateral amygdala
|
0.04 arbitrary units
Standard Deviation 0.11
|
0.00 arbitrary units
Standard Deviation 0.13
|
0.03 arbitrary units
Standard Deviation .013
|
0.05 arbitrary units
Standard Deviation .011
|
-0.00 arbitrary units
Standard Deviation 0.09
|
0.05 arbitrary units
Standard Deviation 0.14
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amygdala Response to Fearful Faces Stimuli
Early-cycle: Left central amygdala
|
0.00 arbitrary units
Standard Deviation 0.15
|
0.05 arbitrary units
Standard Deviation 0.17
|
0.02 arbitrary units
Standard Deviation 0.17
|
0.00 arbitrary units
Standard Deviation 0.15
|
0.05 arbitrary units
Standard Deviation 0.19
|
0.04 arbitrary units
Standard Deviation 0.23
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amygdala Response to Fearful Faces Stimuli
Early-cycle: Right central amygdala
|
0.06 arbitrary units
Standard Deviation 0.15
|
0.05 arbitrary units
Standard Deviation 0.14
|
0.08 arbitrary units
Standard Deviation 0.15
|
0.09 arbitrary units
Standard Deviation 0.14
|
0.01 arbitrary units
Standard Deviation 0.16
|
0.01 arbitrary units
Standard Deviation 0.18
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amygdala Response to Fearful Faces Stimuli
Mid-cycle: Left basolateral amygdala
|
—
|
—
|
—
|
—
|
—
|
—
|
0.07 arbitrary units
Standard Deviation 0.14
|
0.02 arbitrary units
Standard Deviation 0.09
|
0.09 arbitrary units
Standard Deviation .013
|
0.02 arbitrary units
Standard Deviation 0.11
|
0.04 arbitrary units
Standard Deviation 0.10
|
0.06 arbitrary units
Standard Deviation 0.10
|
|
Amygdala Response to Fearful Faces Stimuli
Mid-cycle: Right basolateral amygdala
|
—
|
—
|
—
|
—
|
—
|
—
|
0.09 arbitrary units
Standard Deviation 0.12
|
0.06 arbitrary units
Standard Deviation 0.11
|
0.07 arbitrary units
Standard Deviation 0.13
|
-0.04 arbitrary units
Standard Deviation 0.16
|
0.00 arbitrary units
Standard Deviation 0.07
|
0.07 arbitrary units
Standard Deviation 0.12
|
|
Amygdala Response to Fearful Faces Stimuli
Mid-cycle: Left central amygdala
|
—
|
—
|
—
|
—
|
—
|
—
|
0.03 arbitrary units
Standard Deviation 0.13
|
0.01 arbitrary units
Standard Deviation 0.13
|
0.04 arbitrary units
Standard Deviation 0.14
|
0.03 arbitrary units
Standard Deviation 0.15
|
0.02 arbitrary units
Standard Deviation 0.13
|
0.05 arbitrary units
Standard Deviation 0.14
|
|
Amygdala Response to Fearful Faces Stimuli
Mid-cycle: Right central amygdala
|
—
|
—
|
—
|
—
|
—
|
—
|
0.03 arbitrary units
Standard Deviation 0.17
|
0.04 arbitrary units
Standard Deviation 0.12
|
0.08 arbitrary units
Standard Deviation 0.14
|
-0.05 arbitrary units
Standard Deviation 0.09
|
-0.02 arbitrary units
Standard Deviation 0.16
|
0.09 arbitrary units
Standard Deviation 0.11
|
PRIMARY outcome
Timeframe: Early-cycle for Cohort 1 (mean 4.5 (sd=1.5) days following onset of menstrual period) or Mid-cycle for cohort 2 (mean 5.5 (sd=1.4) days following a positive urine luteinizing hormone test) during cycles 2 and 3 (each cycle is an average of 28 days)Population: Cohort 1 was examined during the early-cycle, while Cohort 2 was examined mid-cycle.
Indicators of fear conditioning are assessed by fMRI during the fear conditioning tasks. Deficits in fear inhibition have been present in persons with PTSD and during phases of the ovarian cycle. The amygdala is subdivided into the basolateral amygdala and central amygdala. Across voxels in each region a contrast estimate of conditioned stimulation (CS)+ (conditioned threat cues) \> CS- (conditioned safety cues) was extracted. The contrast estimate reflects the magnitude of BOLD activation difference between two experimental conditions. Contrast estimates are an arbitrary, unitless comparison of fMRI BOLD signal units of one experimental condition versus another. Positive values indicate strong responsivity to conditioned threats, which could indicate either fear- or memory-related responses. Strong positive values indicate high responsivity to the conditioned threat (CS+), a pattern often associated with PTSD. Negative values indicate greater responsivity to safety cues (CS-).
Outcome measures
| Measure |
Cohort 1: PTSD Receiving Placebo
n=19 Participants
Participants with PTSD during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 1: PTSD Receiving Estradiol
n=18 Participants
Participants with PTSD during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Trauma Control Receiving Estradiol
n=18 Participants
Participants with trauma exposure without PTSD during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Trauma Control Receiving Placebo
n=17 Participants
Participants with trauma exposure without PTSD during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 1: Healthy Controls Receiving Estradiol
n=19 Participants
Participants without trauma history or psychiatric disorder during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Healthy Controls Receiving Placebo
n=19 Participants
Participants without trauma history or psychiatric disorder during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 2: PTSD Receiving Estradiol
n=12 Participants
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: PTSD Receiving Placebo
n=15 Participants
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
Cohort 2: Trauma Control Receiving Estradiol
n=15 Participants
Participants with trauma exposure without PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: Trauma Control Receiving Placebo
n=14 Participants
Participants with trauma exposure without PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
Cohort 2: Healthy Control Receiving Estradiol
n=18 Participants
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: Healthy Control Receiving Placebo
n=16 Participants
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Amygdala Response to Fear Conditioning Task
Early-cycle: Basolateral amygdala
|
-0.05 arbitrary units
Standard Deviation 0.53
|
.013 arbitrary units
Standard Deviation 0.31
|
-0.03 arbitrary units
Standard Deviation 0.41
|
-0.07 arbitrary units
Standard Deviation 0.34
|
0.06 arbitrary units
Standard Deviation 0.36
|
0.17 arbitrary units
Standard Deviation 0.29
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amygdala Response to Fear Conditioning Task
Early-cycle: Central amygdala
|
0.19 arbitrary units
Standard Deviation 0.32
|
0.37 arbitrary units
Standard Deviation 0.33
|
0.08 arbitrary units
Standard Deviation 0.39
|
0.17 arbitrary units
Standard Deviation 0.37
|
0.36 arbitrary units
Standard Deviation 0.36
|
0.37 arbitrary units
Standard Deviation 0.27
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amygdala Response to Fear Conditioning Task
Mid-cycle: Basolateral amygdala
|
—
|
—
|
—
|
—
|
—
|
—
|
0.13 arbitrary units
Standard Deviation 0.44
|
0.16 arbitrary units
Standard Deviation 0.38
|
-0.07 arbitrary units
Standard Deviation 0.47
|
-0.13 arbitrary units
Standard Deviation 0.43
|
0.09 arbitrary units
Standard Deviation 0.43
|
0.04 arbitrary units
Standard Deviation 0.36
|
|
Amygdala Response to Fear Conditioning Task
Mid-cycle: Central amygdala
|
—
|
—
|
—
|
—
|
—
|
—
|
0.30 arbitrary units
Standard Deviation 0.40
|
0.19 arbitrary units
Standard Deviation 0.32
|
0.12 arbitrary units
Standard Deviation 0.54
|
0.19 arbitrary units
Standard Deviation 0.33
|
0.18 arbitrary units
Standard Deviation 0.48
|
0.17 arbitrary units
Standard Deviation 0.28
|
PRIMARY outcome
Timeframe: Early-cycle for Cohort 1 (mean 4.5 (sd=1.5) days following onset of menstrual period) or Mid-cycle for cohort 2 (mean 5.5 (sd=1.4) days following a positive urine luteinizing hormone test) during cycles 2 and 3 (each cycle is an average of 28 days)Population: Cohort 1 was examined during the early-cycle, while Cohort 2 was examined mid-cycle.
Indicators of fear extinction are assessed by fMRI during the fear extinction tasks. Fear extinction is impaired in persons with PTSD and depends on the vmPFC and its inhibition of amygdala responses to threat stimuli. The vmPFC region is defined using the anatomical boundaries of Brodmann area 25 (BA25). Across voxels in this region, a mean contrast estimate of CS+ \> CS- in late extinction was extracted. The contrast estimate reflects the magnitude of BOLD activation difference between experimental conditions. Contrast estimates are a unitless comparison of fMRI BOLD signal units of one experimental condition versus another. These values indicate responsivity to conditioned threats. For the vmPFC, a positive value often indicates regulation of emotion or fear now that the threat cues have been extinguished. Strong positive values indicate higher engagement of this region to the conditioned threat (CS+). Negative values indicate higher engagement of this region to safety cues (CS-).
Outcome measures
| Measure |
Cohort 1: PTSD Receiving Placebo
n=18 Participants
Participants with PTSD during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 1: PTSD Receiving Estradiol
n=16 Participants
Participants with PTSD during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Trauma Control Receiving Estradiol
n=19 Participants
Participants with trauma exposure without PTSD during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Trauma Control Receiving Placebo
n=19 Participants
Participants with trauma exposure without PTSD during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 1: Healthy Controls Receiving Estradiol
n=16 Participants
Participants without trauma history or psychiatric disorder during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Healthy Controls Receiving Placebo
n=17 Participants
Participants without trauma history or psychiatric disorder during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 2: PTSD Receiving Estradiol
n=13 Participants
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: PTSD Receiving Placebo
n=16 Participants
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
Cohort 2: Trauma Control Receiving Estradiol
n=15 Participants
Participants with trauma exposure without PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: Trauma Control Receiving Placebo
n=12 Participants
Participants with trauma exposure without PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
Cohort 2: Healthy Control Receiving Estradiol
n=16 Participants
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: Healthy Control Receiving Placebo
n=16 Participants
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ventromedial Prefrontal Cortex (vmPFC) Activation During the Fear Extinction Task
Early cycle
|
-0.02 arbitrary units
Standard Deviation 0.04
|
-0.01 arbitrary units
Standard Deviation 0.07
|
-0.03 arbitrary units
Standard Deviation 0.05
|
-0.00 arbitrary units
Standard Deviation 0.05
|
0.01 arbitrary units
Standard Deviation 0.05
|
0.00 arbitrary units
Standard Deviation 0.07
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ventromedial Prefrontal Cortex (vmPFC) Activation During the Fear Extinction Task
Mid-cycle
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.00 arbitrary units
Standard Deviation 0.06
|
0.02 arbitrary units
Standard Deviation 0.06
|
0.02 arbitrary units
Standard Deviation 0.05
|
-0.00 arbitrary units
Standard Deviation 0.08
|
-0.00 arbitrary units
Standard Deviation 0.03
|
-0.00 arbitrary units
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Early-cycle for Cohort 1 (mean 4.5 (sd=1.5) days following onset of menstrual period) or Mid-cycle for cohort 2 (mean 5.5 (sd=1.4) days following a positive urine luteinizing hormone test) during cycles 2 and 3 (each cycle is an average of 28 days)Population: This analysis includes participants with PTSD or trauma exposure; healthy control participants did not complete the PCL-5.
The severity of self-reported PTSD symptoms will be assessed with the PCL-5. The PCL-5 asks participants to recall the worst stressful event that is currently bothering them the most. Keeping this event in mind, participants respond to 20 questions indicating how bothered they have been by PTSD symptoms. Responses are on a 5-point scale, where 0 = not bothered at all and 4 = extremely bothered. Total raw scores range from 0 to 80 where higher scores indicate greater distress from PTSD symptoms.
Outcome measures
| Measure |
Cohort 1: PTSD Receiving Placebo
n=19 Participants
Participants with PTSD during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 1: PTSD Receiving Estradiol
n=19 Participants
Participants with PTSD during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Trauma Control Receiving Estradiol
n=22 Participants
Participants with trauma exposure without PTSD during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Trauma Control Receiving Placebo
n=21 Participants
Participants with trauma exposure without PTSD during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 1: Healthy Controls Receiving Estradiol
n=13 Participants
Participants without trauma history or psychiatric disorder during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Healthy Controls Receiving Placebo
n=16 Participants
Participants without trauma history or psychiatric disorder during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 2: PTSD Receiving Estradiol
n=16 Participants
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: PTSD Receiving Placebo
n=14 Participants
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
Cohort 2: Trauma Control Receiving Estradiol
Participants with trauma exposure without PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: Trauma Control Receiving Placebo
Participants with trauma exposure without PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
Cohort 2: Healthy Control Receiving Estradiol
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: Healthy Control Receiving Placebo
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5)
|
35.3 score on a scale
Standard Deviation 11.8
|
36.9 score on a scale
Standard Deviation 13.3
|
21.2 score on a scale
Standard Deviation 12.8
|
20.2 score on a scale
Standard Deviation 14.1
|
37.3 score on a scale
Standard Deviation 15.5
|
33.8 score on a scale
Standard Deviation 16.1
|
11.8 score on a scale
Standard Deviation 8.4
|
13.9 score on a scale
Standard Deviation 7.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Early-cycle for Cohort 1 (mean 4.5 (sd=1.5) days following onset of menstrual period) or Mid-cycle for cohort 2 (mean 5.5 (sd=1.4) days following a positive urine luteinizing hormone test) during cycles 2 and 3 (each cycle is an average of 28 days)The BDI-II is a 21-item instrument assessing depression. Respondents indicate how severe their feelings of depression symptoms are on a scale of 0 (not present) to 3 (most severe). Total raw scores range from 0 to 63, with higher scores indicating greater severity of depression.
Outcome measures
| Measure |
Cohort 1: PTSD Receiving Placebo
n=19 Participants
Participants with PTSD during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 1: PTSD Receiving Estradiol
n=19 Participants
Participants with PTSD during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Trauma Control Receiving Estradiol
n=22 Participants
Participants with trauma exposure without PTSD during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Trauma Control Receiving Placebo
n=21 Participants
Participants with trauma exposure without PTSD during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 1: Healthy Controls Receiving Estradiol
n=19 Participants
Participants without trauma history or psychiatric disorder during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Healthy Controls Receiving Placebo
n=20 Participants
Participants without trauma history or psychiatric disorder during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 2: PTSD Receiving Estradiol
n=13 Participants
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: PTSD Receiving Placebo
n=16 Participants
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
Cohort 2: Trauma Control Receiving Estradiol
n=16 Participants
Participants with trauma exposure without PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: Trauma Control Receiving Placebo
n=15 Participants
Participants with trauma exposure without PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
Cohort 2: Healthy Control Receiving Estradiol
n=18 Participants
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: Healthy Control Receiving Placebo
n=15 Participants
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Beck Depression Inventory (BDI)
|
22.3 score on a scale
Standard Deviation 10.2
|
24.2 score on a scale
Standard Deviation 9.9
|
12.6 score on a scale
Standard Deviation 9.4
|
12.4 score on a scale
Standard Deviation 8.5
|
6.6 score on a scale
Standard Deviation 5.8
|
6.4 score on a scale
Standard Deviation 5.3
|
24.4 score on a scale
Standard Deviation 11.9
|
22.3 score on a scale
Standard Deviation 11.5
|
8.6 score on a scale
Standard Deviation 7.0
|
6.4 score on a scale
Standard Deviation 6.3
|
9.1 score on a scale
Standard Deviation 9.3
|
5.9 score on a scale
Standard Deviation 5.2
|
Adverse Events
Cohort 1: PTSD Receiving Estradiol
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 1: PTSD Receiving Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1: Trauma Control Receiving Estradiol
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 1: Trauma Control Receiving Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 1: Healthy Controls Receiving Estradiol
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 1: Healthy Controls Receiving Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2: PTSD Receiving Estradiol
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: PTSD Receiving Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2: Trauma Control Receiving Estradiol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: Trauma Control Receiving Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: Healthy Control Receiving Estradiol
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: Healthy Control Receiving Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: PTSD Receiving Estradiol
n=21 participants at risk
Participants with PTSD during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: PTSD Receiving Placebo
n=19 participants at risk
Participants with PTSD during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 1: Trauma Control Receiving Estradiol
n=22 participants at risk
Participants with trauma exposure without PTSD during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Trauma Control Receiving Placebo
n=21 participants at risk
Participants with trauma exposure without PTSD during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 1: Healthy Controls Receiving Estradiol
n=20 participants at risk
Participants without trauma history or psychiatric disorder during the cycle that they applied the estradiol patches prior to the MRI scan.
|
Cohort 1: Healthy Controls Receiving Placebo
n=21 participants at risk
Participants without trauma history or psychiatric disorder during the cycle that they applied the placebo patches prior to the MRI scan.
|
Cohort 2: PTSD Receiving Estradiol
n=14 participants at risk
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: PTSD Receiving Placebo
n=18 participants at risk
Participants with PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
Cohort 2: Trauma Control Receiving Estradiol
n=18 participants at risk
Participants with trauma exposure without PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: Trauma Control Receiving Placebo
n=19 participants at risk
Participants with trauma exposure without PTSD begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
Cohort 2: Healthy Control Receiving Estradiol
n=18 participants at risk
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used estradiol patches before the MRI.
|
Cohort 2: Healthy Control Receiving Placebo
n=16 participants at risk
Participants without trauma history or psychiatric disorder begin daily urine ovulation tests on Day 11 of their first cycle, and record the results with the Clue app. During subsequent months of cycle monitoring, the MRI is scheduled 5-7 days after they record a positive ovulation test (during luteal phase). During this cycle they used placebo patches before the MRI.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Increase in mental health symptoms
|
4.8%
1/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
9.1%
2/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
4.8%
1/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
4.8%
1/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
14.3%
2/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
16.7%
3/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
General disorders
Migraines
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
5.3%
1/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
Surgical and medical procedures
Headache during MRI scan
|
9.5%
2/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
Surgical and medical procedures
Discomfort with MRI environment
|
4.8%
1/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
9.5%
2/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
Skin and subcutaneous tissue disorders
Itchiness at site of patch
|
4.8%
1/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
5.3%
1/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
5.0%
1/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
4.8%
1/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
5.6%
1/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
5.6%
1/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
Injury, poisoning and procedural complications
Injured toe
|
4.8%
1/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
Injury, poisoning and procedural complications
Car accident
|
4.8%
1/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
4.8%
1/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
Vascular disorders
Edema in leg
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
5.3%
1/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
Reproductive system and breast disorders
Menstrual spotting
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
4.5%
1/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
Reproductive system and breast disorders
Cramps
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
4.5%
1/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
5.6%
1/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
Surgical and medical procedures
Nausea during MRI
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
4.5%
1/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
Skin and subcutaneous tissue disorders
Redness at site of patch
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
4.5%
1/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
5.0%
1/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
4.8%
1/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
General disorders
Brief hot flash after patch placement
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
4.8%
1/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
Musculoskeletal and connective tissue disorders
Worsening neck pain
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
4.8%
1/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
General disorders
Chest pain
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
5.0%
1/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
General disorders
Seasonal allergies
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
5.0%
1/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
Cardiac disorders
Low heart rate
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
7.1%
1/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
Surgical and medical procedures
Dizziness during MRI scan
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
5.6%
1/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
General disorders
Continuing health problem
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
5.6%
1/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
Social circumstances
Continuing stress
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
5.6%
1/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
Gastrointestinal disorders
Nausea after applying patch
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
5.6%
1/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
6.2%
1/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/22 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/20 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/21 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/14 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/19 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
0.00%
0/18 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
6.2%
1/16 • Information on adverse events was collected beginning at the time of randomization and continued to 30 days after the final study visit. The longest duration of follow-up for adverse events was 830 days as participants enrolled prior to the Coronavirus Disease 2019 (COVID-19) pandemic were followed during the time that research was suspended until their participation could be completed upon the study resuming.
Adverse events were queried at each study visit, asking about any events occurring in the time since application of the E2 or placebo patch. A final adverse event screen was conducted by phone 30 days after the final study visit. Information about all adverse events were collected, whether or not they were related to study procedures
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place