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

Marianne Andersen

Status

Enrolling

Conditions

Transgenderism

Study type

Observational

Funder types

Other

Identifiers

NCT04254354

BICTX01

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Transgender men

Exclusion criteria

none