Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version

NCT07092527 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 8130871R01HD111650-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Evidence of Luteal Activity (ELA)

  Evidence of Luteal Activity (ELA), as defined by serum progesterone level above 3 ng/mL in transgender men initiating testosterone replacement therapy.

  Through study completion, an average of 7 months.

• Determination of Pulsatile Luteinizing Hormone (LH) Secretion

  Subjects will have baseline measurement of serum LH immediately followed by frequent blood sampling at 10-min intervals for 8 h. We will measure LH pulse frequency, the number of LH pulses per 8 hours.

  Through study completion, an average of 7 months.

• Uterine Bleeding Pattern

  All subjects will complete a daily uterine bleeding log using REDCap®

  Through study completion, an average of 7 months.

Secondary Outcomes (5)

• Evaluate Serum FSH

  Through study completion, an average of 7 months.

• Evaluate Serum AMH

  Through study completion, an average of 7 months.

• Evaluate Serum LH

  Through study completion, an average of 7 months.

• Evaluate Serum Estradiol

  Through study completion, an average of 7 months.

• Evaluate Serum Testosterone

  Through study completion, an average of 7 months.

Study Arms (2)

Transgender Men (TGM) initiating Testosterone Replacement Therapy (TRT)

ACTIVE COMPARATOR

Transgender men/non-binary/non-gender-conforming initiating testosterone replacement therapy

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

Cisgender Female (CGF) control group

NO INTERVENTION

Cisgender females serving as a control group

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.

Also known as: Testosterone Replacement Therapy

Transgender Men (TGM) initiating Testosterone Replacement Therapy (TRT)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Cisgender females; Transgender males/non-binary/gender non-conforming initiating testosterone replacement therapy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of California, San Diego

San Diego, California, 92037, United States

RECRUITING

Related Publications (35)

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  BACKGROUND

Related Links

• Pfizer Inc. Depo®-Testosterone (testosterone cypionate injection, USP0 \[package insert\]. U.S. Food and Drug Administration website.

MeSH Terms

Conditions

Transsexualism

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Study Officials

• Antoni Duleba, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoni Duleba, MD

CONTACT

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

Marisa Hildebrand, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 30, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): November 15, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)