Trial Outcomes & Findings for Ovarian Function With ENG Implant and UPA Use (NCT NCT04291001)
NCT ID: NCT04291001
Last Updated: 2024-07-12
Results Overview
Ovulation will be monitored by ultrasound and serum LH and progesterone levels
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
40 participants
Primary outcome timeframe
5 days
Results posted on
2024-07-12
Participant Flow
Participant milestones
| Measure |
ENG Implant Alone
Women will receive a contraceptive implant in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.
ENG implant: This is an FDA-approved contraceptive device
|
ENG Implant Plus Oral UPA
Women will receive a contraceptive implant and oral UPA the same day in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.
ENG implant: This is an FDA-approved contraceptive device
oral ulipristal acetate: This is an FDA-approved oral emergency contraceptive
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ovarian Function With ENG Implant and UPA Use
Baseline characteristics by cohort
| Measure |
ENG Implant Alone
n=20 Participants
Women will receive a contraceptive implant in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.
ENG implant: This is an FDA-approved contraceptive device
|
ENG Implant Plus Oral UPA
n=20 Participants
Women will receive a contraceptive implant and oral UPA the same day in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.
ENG implant: This is an FDA-approved contraceptive device
oral ulipristal acetate: This is an FDA-approved oral emergency contraceptive
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.2 years
STANDARD_DEVIATION 3.9 • n=99 Participants
|
24.3 years
STANDARD_DEVIATION 3.5 • n=107 Participants
|
23.7 years
STANDARD_DEVIATION 3.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
|
BMI
|
24.2 kg/m^2
STANDARD_DEVIATION 2.7 • n=99 Participants
|
23.7 kg/m^2
STANDARD_DEVIATION 3.1 • n=107 Participants
|
24.0 kg/m^2
STANDARD_DEVIATION 2.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: 5 daysPopulation: Outcome Measure was pre-specified to assess "ENG Implant Alone"
Ovulation will be monitored by ultrasound and serum LH and progesterone levels
Outcome measures
| Measure |
ENG Implant Alone
n=20 Participants
Participants will receive a contraceptive implant in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.
ENG implant: This is an FDA-approved contraceptive device
|
ENG Implant Plus Oral UPA
ParticipantsUPA the same day in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.
ENG implant: This is an FDA-approved contraceptive device
oral ulipristal acetate: This is an FDA-approved oral emergency contraceptive
|
|---|---|---|
|
Number of Participants With Ovulation With Implant-alone
|
7 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 5 daysPopulation: Outcome Measure was pre-specified to assess "ENG Implant plus oral UPA"
Ovulation will be monitored by ultrasound and serum LH and progesterone levels
Outcome measures
| Measure |
ENG Implant Alone
Participants will receive a contraceptive implant in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.
ENG implant: This is an FDA-approved contraceptive device
|
ENG Implant Plus Oral UPA
n=19 Participants
ParticipantsUPA the same day in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.
ENG implant: This is an FDA-approved contraceptive device
oral ulipristal acetate: This is an FDA-approved oral emergency contraceptive
|
|---|---|---|
|
Number of Participants With Ovulation With Implant and Same Day UPA
|
0 Participants
|
13 Participants
|
Adverse Events
ENG Implant Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ENG Implant Plus Oral UPA
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ENG Implant Alone
n=20 participants at risk
Participants will receive a contraceptive implant in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.
ENG implant: This is an FDA-approved contraceptive device
|
ENG Implant Plus Oral UPA
n=20 participants at risk
ParticipantsUPA the same day in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.
ENG implant: This is an FDA-approved contraceptive device
oral ulipristal acetate: This is an FDA-approved oral emergency contraceptive
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/20 • 30 days after final study visit, up to 44 days
|
5.0%
1/20 • Number of events 1 • 30 days after final study visit, up to 44 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place