Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorUniversity of California, San Diego
About this trial
This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Aged 18-35
Plan to initiate testosterone therapy
Disqualifiers
Pregnant
Incarcerated
Known cognitive impairment or institutionalized
Hemoglobin less than 11 gm/dl at screening evaluation
Trial design
Design model
Parallel
Treatments tested in this trial
Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution
DrugParticipants in the initiating group will receive weekly doses of testosterone for gender-affirming care.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Transgender Men (TGM) initiating Testosterone Replacement Therapy (TRT)Active comparator 1 intervention
Group B: Cisgender Female (CGF) control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Evidence of Luteal Activity (ELA)
Evidence of Luteal Activity (ELA), as defined by serum progesterone level above 3 ng/mL in transgender men initiating testosterone replacement therapy.
Time frame
Through study completion, an average of 7 months.2
Determination of Pulsatile Luteinizing Hormone (LH) Secretion
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.
Time frame
Through study completion, an average of 7 months.3
Uterine Bleeding Pattern
All subjects will complete a daily uterine bleeding log using REDCap®
Time frame
Through study completion, an average of 7 months.Secondary outcomes
1
Evaluate Serum FSH
Measurement of serum follicle-stimulating hormone (FSH) levels
Time frame
Through study completion, an average of 7 months.2
Evaluate Serum AMH
Measurement of serum anti-mullerian hormone (AMH) levels
Time frame
Through study completion, an average of 7 months.3
Evaluate Serum LH
Measurement of serum luteinizing hormone (LH) levels
Time frame
Through study completion, an average of 7 months.4
Evaluate Serum Estradiol
Measurement of serum estradiol levels
Time frame
Through study completion, an average of 7 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Diego
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov