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Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04254354
Study type Observational
Source Odense University Hospital
Contact marianne andersen, Professor
Phone +4565412502
Email msa@rsyd.dk
Status Recruiting
Phase
Start date March 3, 2020
Completion date January 1, 2044

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