Recruiting

Androgens

Sponsor:

UCLA

Code:

NCT07092527

Conditions

Transgenderism

Reproductive Issues

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution

Study Details

Brief summary:

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

Conditions

Transgenderism

Reproductive Issues

Study ID

NCT07092527

Start date

Dec 5, 2025

Status verified date

Jan, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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

Interventions

Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution

Participants in the initiating group will receive weekly doses of testosterone for gender-affirming care.

Primary outcome measure

  • Evidence of Luteal Activity (ELA) [ Time Frame: Through study completion, an average of 7 months. ]
  • Determination of Pulsatile Luteinizing Hormone (LH) Secretion [ Time Frame: Through study completion, an average of 7 months. ]
  • Uterine Bleeding Pattern [ Time Frame: Through study completion, an average of 7 months. ]

Central Contacts and Locations

Central contacts

Antoni Duleba, MD

619-804-4765aduleba@health.ucsd.edu

Marisa Hildebrand, MPH

619-804-4765mchildeb@health.ucsd.edu

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92037

Contacts

Antoni Duleba, MD

619-804-4765aduleba@health.ucsd.edu

Marisa Hildebrand, MPH

619-804-4765mchildeb@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Jan 15, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-01-15.