Hormone Secretion in Transgender Males

NCT04321551 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 200395
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim 1 utilizes prospective clinical studies in TGN to test the hypothesis that prolonged exogenous androgens alter menstrual cyclicity by inhibiting gonadotropin secretion, steroid hormone release, and ovulation. We will utilize a clinical trial of TRT to evaluate T suppression of ovarian follicle and hormone dynamics (Aim 1A) and LH pulsatility (Aim 1B).

Conditions

Transgender; Healthy

Keywords

Testosterone therapy

Outcome Measures

Primary Outcomes (1)

• Evidence of Luteal Activity

  The primary endpoint will be Evidence of Luteal Activity (ELA), as defined by a 3-fold increase in urinary pregnanediol glucuronide level over baseline.

  Baseline, 12 weeks, 24 weeks, and 32 weeks

Study Arms (1)

Provocative Hormonal Testing

EXPERIMENTAL

TGN subjects will undergo baseline endocrine and menstrual cycle evaluation, followed by intramuscular (i.m.) administration of testosterone cypionate (TC) 50 mg (standard dose) every 7 d for 32 wks (Fig. 8). After 24 wks, an aromatase inhibitor, letrozole (LET, 2.5 mg/d oral), will be co-administered with TC for 8 wks to block estrogen synthesis and examine whether T's effects are independent of E2 signaling.

Drug: Testosterone Cyp 200Mg/Ml Inj (in Oil); Drug: Letrozole

Interventions

Testosterone Cyp 200Mg/Ml Inj (in Oil) DRUG

Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1- oxopropoxy)-, (17ß)-. Its molecular formula is C27H40O3, and the molecular weight 412.61.

Also known as: Depo-Testosterone

Provocative Hormonal Testing

Letrozole DRUG

Letrozole is a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1H-1,2,4-Triazol-1- ylmethylene)dibenzonitrile. Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31, empirical formula C17H11N5, and a melting range of 184°C to 185°C. Letrozole is available as 2.5 mg tablets for oral administration.

Also known as: Femara

Provocative Hormonal Testing

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Cisgender females Transgender males Gender non-binary individuals
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

* Self-identified transgender or non-binary person assigned female at birth * No history of prior testosterone therapy * Regular menstrual cycles * Body mass index 18 - 35 * Hemoglobin greater than than 11 gm/dl at screening evaluation * Presence of uterus and both ovaries at time of consent * Able to provide informed consent * No current endocrine disease- including, but not limited to, pituitary disease, adrenal disease, androgen secreting tumor, polycystic ovary syndrome, diabetes, or untreated thyroid disease. * Absence of cancer and any renal, hepatic, or cardiac disease * No current use of endocrine modulating medications (including, but not limited to, progestin therapy, estrogen containing medications, metformin, insulin) * No history of radiation or surgery involving brain, abdomen, or pelvis

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Diego: lead

MeSH Terms

Interventions

testosterone 17 beta-cypionate; Letrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics, Gynecology, and Reproductive Sciences

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 25, 2020
• Study Start: July 1, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share