NCT07092527 Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version
| NCT ID | NCT07092527 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, San Diego |
| Condition | Transgenderism |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-12-05 |
| Primary Completion | 2028-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2025-12-05 with a primary completion date of 2028-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.
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
Contact & Investigator
Antoni Duleba, MD
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT07092527 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 35 Years, studying Transgenderism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07092527 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07092527 currently recruiting?
Yes, NCT07092527 is actively recruiting participants. Contact the research team at aduleba@health.ucsd.edu for enrollment information.
Where is the NCT07092527 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT07092527 clinical trial?
NCT07092527 is sponsored by University of California, San Diego. The principal investigator is Antoni Duleba, MD at University of California, San Diego. The trial plans to enroll 80 participants.