Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version

University of California San Diego

Status and phase

Enrolling

Phase 4

Conditions

Reproductive Issues

Transgenderism

Treatments

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

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07092527

813087

1R01HD111650-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Enrollment

80 estimated patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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