Pubertal Blockade and Hormone Therapy in Transgender Youth

Completed

Conditions studied: Gender Identity, Gender Dysphoria, Gender Identity Disorder in Adolescence and Adulthood

In brief

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.

Key facts

Study ID

NCT03557268

Run by

University of Colorado, Denver

People needed

19

Starts

2018-06-19

Expected to finish

2020-09-09

Last updated by the study team

2020-09-29

Who can join

Age: 13 and older, up to 16. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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