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Recruiting NCT04596592

Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

Trial Parameters

Condition Transgenderism
Sponsor University of Colorado, Denver
Study Type OBSERVATIONAL
Phase N/A
Enrollment 90
Sex ALL
Min Age 13 Years
Max Age 16 Years
Start Date 2021-02-15
Completion 2026-07-31

Brief Summary

To evaluate the effect of estradiol with or without a prior gonadotropin releasing hormone analogue on insulin sensitivity and vascular function in transgender females compared to cisgender controls.

Eligibility Criteria

Inclusion Criteria (transgender females): * Identify as a transgender female * Age 13-16 years at the time of enrollment * If on a gonadotropin releasing hormone analogue, \> 6 months exposure * Plan to start estradiol clinically in \< 4 months Inclusion Criteria (cisgender males and females): * Males and females ages 13-16 years Exclusion Criteria: * Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures * Antipsychotic medication use * Type 1 or 2 diabetes (by medical history) * Polycystic ovarian syndrome (PCOS for cisgender females) * Hypertension (resting BP ≥ 140/90 mm/Hg) * Weight\> 400 lbs * On oral progesterone medications (including oral progesterone or progestin, combined oral contraceptives or etonogestrel implant) * Pregnancy (for cisgender females)

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