NCT04254354

Transgender Men, Non-binary Persons and Testosterone Treatment BODY IDENTITY CLINIC

Masculinizing Testosterone Treatment and Effects on Preclinical Cardiovascular Disease, Muscle Strength and Power, Aggression, Physical Fitness and Respiratory Function in Transgender Men,Body Identity Clinic (BIC)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Marianne Andersen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to investigate transgender men and non-binary persons before and during testosterone treatment. The study will focus on: * Cardiovascular status * Muscle strenght and power * Aggression and quality of life * Cardiac and respiratory function

Detailed description

Introduction: The number of individuals with gender dysphoria seeking gender-affirming treatment is increasing. The short- and long-term effects of masculinizing treatment with testosterone are debated as serum testosterone increase up to 20-fold compared to cisgender women. We hypothesize that, testosterone treatment is associated with non-calcified coronary plaque (NCP) development in transgender men. Methods and analyses: Prospective, single-center, observational cohort study at the Body Identity Clinic (BIC), Odense University Hospital, Denmark, where all investigations are performed at inclusion and after 1, 3, 5 and 10 years of testosterone therapy. Ethics and dissemination: The Regional Committees on Health Research Ethics for Southern Denmark (S-20190108) and the Danish Data Protection Agency approved the study (19/27572). Signed informed consent will be obtained from all participants. All findings will be published in peer-reviewed journals or at scientific conferences.

Conditions

• Transgenderism

Timeline

• Start date: 2020-03-03
• Primary completion: 2044-01-01
• Completion: 2044-01-01
• First posted: 2020-02-05
• Last updated: 2025-08-13

Locations

1 site across 1 country: Denmark