Trial Outcomes & Findings for Androgen Effects on the Reproductive Neuroendocrine Axis (NCT NCT06450405)
NCT ID: NCT06450405
Last Updated: 2025-07-22
Results Overview
Evidence of Luteal Activity (ELA), as defined by serum progesterone level above 3 ng/mL in transgender men initiating testosterone replacement therapy.
TERMINATED
PHASE4
2 participants
Through study completion, an average of 7 months.
2025-07-22
Participant Flow
The researchers enrolled 2 cisgender female participants before the study was terminated. Enrolled CGFs signed consent forms, but did not participate in any study activities. There is no analyzable data.
Participant milestones
| Measure |
TGM Initiating TRT
Transgender men/non-binary/non-gender-conforming initiating testosterone replacement therapy
Testosterone Cypionate 50 MG/ML Injectable Solution: Participants in the initiating group will receive weekly doses of testosterone for gender-affirming care.
|
CGF Control Group
Cisgender females serving as a control group
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
TGM Initiating TRT
Transgender men/non-binary/non-gender-conforming initiating testosterone replacement therapy
Testosterone Cypionate 50 MG/ML Injectable Solution: Participants in the initiating group will receive weekly doses of testosterone for gender-affirming care.
|
CGF Control Group
Cisgender females serving as a control group
|
|---|---|---|
|
Overall Study
Study funding terminated.
|
0
|
2
|
Baseline Characteristics
Androgen Effects on the Reproductive Neuroendocrine Axis
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Through study completion, an average of 7 months.Population: The study sponsor terminated the grant funding before any data, besides names and signatures on consent forms, were collected. There are no data to analyze. No data will be analyzed in the future.
Evidence of Luteal Activity (ELA), as defined by serum progesterone level above 3 ng/mL in transgender men initiating testosterone replacement therapy.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through study completion, an average of 7 months.Population: The study sponsor terminated the grant funding before any data, besides names and signatures on consent forms, were collected. There are no data to analyze. No data will be analyzed in the future.
Subjects will have baseline measurement of serum LH immediately followed by frequent blood sampling at 10-min intervals for 8 h. We will measure LH pulse frequency, the number of LH pulses per 8 hours.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through study completion, an average of 7 months.Population: The study sponsor terminated the grant funding before any data, besides names and signatures on consent forms, were collected. There are no data to analyze. No data will be analyzed in the future.
All subjects will complete a daily uterine bleeding log using REDCap®
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 7 months.Population: The study sponsor terminated the grant funding before any data, besides names and signatures on consent forms, were collected. There are no data to analyze. No data will be analyzed in the future.
Measurement of serum FSH, AMH, LH, estradiol, and testosterone levels
Outcome measures
Outcome data not reported
Adverse Events
TGM Initiating TRT
CGF Control Group
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