NCT06450405

Androgen Effects on the Reproductive Neuroendocrine Axis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Transgenderism
• Reproductive Issues

Interventions

Type	Name	Description
DRUG	Testosterone Cypionate 50 MG/ML Injectable Solution	Participants in the initiating group will receive weekly doses of testosterone for gender-affirming care.

Timeline

• Start date: 2025-02-26
• Primary completion: 2025-02-26
• Completion: 2025-03-03
• First posted: 2024-06-10
• Last updated: 2025-07-22
• Results posted: 2025-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study