RecruitingPhase 4NCT07092527
Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version
Sponsor
University of California, San Diego
Enrollment
80 participants
Start Date
Dec 5, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 35 Years
Inclusion Criteria9
- 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
- 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 Criteria14
- 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
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Interventions
DRUGTestosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution
Participants in the initiating group will receive weekly doses of testosterone for gender-affirming care.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07092527
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