CompletedNot Applicable

Pubertal Blockade and Hormone Therapy in Transgender Youth

United States19 participantsStarted 2018-06-19

Plain-language summary

This study will enroll female-to-male transgender youth who are and are not on a puberty blocker (gonadotropin-releasing hormone analogue) at baseline and 1 and 12 months after starting testosterone. The study will evaluate markers of cardiometabolic health including: insulin sensitivity, laboratory markers, vascular health, body composition, activity/fitness, mitochondrial function and the microbiome.

Who can participate

Age range13 Years – 16 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Identify as female-to-male * Age 13-16 years at the time of enrollment * If on a gonadotropin-releasing hormone analogue, \> 6 months exposure * Plan to start testosterone clinically in \< 6 months. Exclusion Criteria: * Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures * Diabetes * Antipsychotic medication * Hypertension (resting BP ≥ 140/90 mm/Hg) * Weight \> 400 lbs (DXA and MRI limit) * On estrogen and/or progesterone medications

What they're measuring

Change in Insulin sensitivity

Timeframe: Baseline and 12 months after initiation of testosterone.

Change in Vascular Health

Timeframe: Baseline and 12 months after initiation of testosterone.

Trial details

NCT IDNCT03557268

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-09-09

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