Trial Outcomes & Findings for Effect of Progesterone on Testosterone Concentrations and Breast Development in Transwomen (NCT NCT04534881)
NCT ID: NCT04534881
Last Updated: 2024-03-19
Results Overview
Change from baseline till 24 weeks in serum testosterone concentrations between progesterone and placebo groups. Calculated as testosterone levels at 24 weeks minus baseline
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
24 weeks
Results posted on
2024-03-19
Participant Flow
Participant milestones
| Measure |
Progesterone
subjects on active drug (progesterone)
Progesterone 200 MG: Subjects will be randomized to receive generic micronized progesterone 200 mg tablets, to be taken at bedtime daily.
|
Placebo
subjects on placebo
Placebo: Subjects will be randomized to receive placebo tablets, to be taken at bedtime daily.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Progesterone on Testosterone Concentrations and Breast Development in Transwomen
Baseline characteristics by cohort
| Measure |
Progesterone
n=3 Participants
subjects on active drug (progesterone)
Progesterone 200 MG: Subjects will be randomized to receive generic micronized progesterone 200 mg or placebo tablets, to be taken at bedtime daily.
|
Placebo
n=2 Participants
subjects on placebo
Placebo: Subjects will be randomized to receive generic micronized progesterone 200 mg or placebo tablets, to be taken at bedtime daily.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 2.5 • n=99 Participants
|
24.5 years
STANDARD_DEVIATION 0.7 • n=107 Participants
|
28.8 years
STANDARD_DEVIATION 4.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 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
|
PRIMARY outcome
Timeframe: 24 weeksChange from baseline till 24 weeks in serum testosterone concentrations between progesterone and placebo groups. Calculated as testosterone levels at 24 weeks minus baseline
Outcome measures
| Measure |
Progesterone
n=3 Participants
subjects on active drug (progesterone)
Progesterone 200 MG: Subjects will be randomized to receive generic micronized progesterone 200 mg tablets, to be taken at bedtime daily.
|
Placebo
n=2 Participants
subjects on placebo
Placebo: Subjects will be randomized to receive placebo tablets, to be taken at bedtime daily.
|
|---|---|---|
|
Efficacy: Testosterone
|
1.5 ng/dL
Standard Deviation 4
|
-6.4 ng/dL
Standard Deviation 0
|
Adverse Events
Progesterone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place