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Clinical Trial Summary

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


Clinical Trial 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 urinary and 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. Furthermore, the investigators will monitor menstrual cycles and reproductive hormones in TGM who make the personal decision to discontinue TRT, whether it is to pursue fertility or for other reasons. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06450405
Study type Observational
Source University of California, San Diego
Contact Antoni Duleba, MD
Phone 619-804-4765
Email aduleba@health.ucsd.edu
Status Not yet recruiting
Phase
Start date June 1, 2024
Completion date June 1, 2029

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