Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version

Phase 4RecruitingNCT07092527

University of California, San Diego80 enrolled

Overview

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

Testosterone Replacement Therapy (TRT) is the mainstay of gender affirming care for transgender men (TGM) who have male gender identity after female sex assignment at birth. TGM receiving TRT over time exhibit irregular menstrual bleeding, however, the mechanism of menstrual disruption is unknown. Therefore, the investigators propose to evaluate the effect of chronic testosterone (T) exposure on ovarian hormones and pituitary gonadotropin release that determines menstrual cyclicity. The investigators will conduct a detailed study of blood reproductive hormone secretion in TGM before and during TRT as well as in untreated cisgender female (CGF) control subjects who report female gender identity congruent with female sex assignment at birth. The investigators will also perform periodic clinical and ultrasonographic evaluations.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Transgenderism Reproductive Issues

Interventions

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

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of California, San Diego

San Diego, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.