Clinical Trial

Body Composition Assessment in Transgender Population.

Study acronym: BIVATRANS
Completed
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Summary
Gender-affirming hormone therapy (GAHT) is a fundamental component of medical transition in transgender men, promoting body composition changes that align physical characteristics with gender identity and alleviate gender dysphoria. In adults, GAHT typically involves testosterone administration, whereas adolescents may receive gonadotropin-releasing hormone agonists to suppress puberty before initiating testosterone. Despite its general safety when appropriately monitored, findings on GAHT-related changes in body composition and potential cardiovascular implications are inconsistent. Accurate assessment of skeletal muscle mass and fat redistribution is clinically relevant, as conventional anthropometric measures may fail to capture these changes. This study evaluates body composition changes after one year of testosterone therapy in transgender men using bioelectrical impedance vector analysis (BIVA), and explores the utility of muscle ultrasound as an accessible tool for monitoring skeletal muscle and potential differences among testosterone formulations.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-15.
Trial Details
NCT Number NCT07481942
Lead Sponsor Celia Bañuls
Conditions Transgender
Enrollment 70 participants
Start Date 2017-01-01
Primary Completion 2024-12-31 (estimated)
Study Completion 2025-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-23