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Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version
RecruitingPhase 4Healthy volunteers welcome
Who can join
Ages 18 to 35 · Women · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: Transgender/Non-binary Group, Initiating Testosterone Group * 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 * History of regular menstrual cycles (every 24-35 days) at baseline, before beginning TRT Inclusion Criteria: Cisgender Female Group * 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 * Having regular menstrual cycles (every 24-35 days) Exclusion Criteria: All * Pregnant * Incarcerated * Known cognitive impairment or institutionalized * Hemoglobin less than 11 gm/dl at screening evaluation * Weight less than 110 pounds * BMI \<18 or \>35 * Current endocrine disease- including untreated thyroid abnormalities, pituitary or adrenal disease, polycystic ovary syndrome, or androgen producing tumor * Current or recent pregnancy within two months of study enrollment * Current or recent breast feeding within two months of study enrollment * Diabetes, or renal, liver, or heart disease * History of oophorectomy or hysterectomy * History of radiation or surgery involving brain structures and/or pelvis/pelvic organs * Currently taking any medications that may affect their reproductive hormones, such as contraceptive medications, androgens, estrogens, progestins, gonadotropin-releasing hormone (GnRH) antagonists, insulinomimetics, and metformin. * History of prior testosterone therapy
About the study
This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.
What is being tested
- Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution (drug)
Sponsor: University of California, San Diego · Participants: 80 · Started: Dec 5, 2025
Contact the study team
- Antoni Duleba, MD · Phone: 619-804-4765
- Marisa Hildebrand, MPH · Phone: 619-804-4765
Official record on ClinicalTrials.gov — NCT07092527
Locations in the U.S.
| California | University of California, San Diego, San Diego |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.