Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT07092527
Phase
PHASE4
Status
Recruiting
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Conditions

  • Reproductive Issues
  • Transgenderism

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

  • Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution — DRUG
    Participants in the initiating group will receive weekly doses of testosterone for gender-affirming care.

Study Details

This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.

Key Dates

Start date
Dec 5, 2025
Status verified
Jan 2026
Primary completion
Nov 15, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Transgender Men (TGM) initiating Testosterone Replacement Therapy (TRT)
    Transgender men/non-binary/non-gender-conforming initiating testosterone replacement therapy
  • No Intervention: Cisgender Female (CGF) control group
    Cisgender females serving as a control group

Primary Outcome Measure

Evidence of Luteal Activity (ELA) [ Time Frame: Through study completion, an average of 7 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92037
Antoni Duleba, MD
[email protected]
619-804-4765
Marisa Hildebrand, MPH
[email protected]
619-804-4765

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