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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04254354

Enrollment

200

Registered

2020-02-05

Start date

2020-03-03

Completion date

2044-01-01

Last updated

2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transgenderism

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Transgender men

Exclusion criteria

none

Design outcomes

Primary

Measure	Time frame	Description
Effect of testosterone on devellopment of plaques in the heart	10 years	Estimated directly by CCTA, at start, (1 year for early included participants) 5 and 10 years

Secondary

Measure	Time frame	Description
Change in muscle strength and power	10 years	Estimated by low row and accelometer at start, 1, 3, 5, 10 years
Effect of transgender treatment on quality of life	10 years	Estimated by quality of life questionnaire (SF36) at start, 1, 3, 5 and 10 years
Effect of transgender treatment on aggression	10 years	Estimated by aggression questionnaire at start, 1, 3, 5 and 10 years
Changes in maximal oxygen consumption during transgender treatment	10 years	Estimated by test og maximal oxygen consumption (vo2max) at start, 1, 3, 5 and 10 years
Heart function	10 years	Ejection fraction and left ventricular muscle mass are measured by echocardiography at start,(1 for early included participants) 5 and 10 years
Calcium score	10 years	CCTA
Levels of testosterone, estradiol and cortisol	10 years	Measured in serum by LCMS/MS
circulating markers of inflammation	10 years	CRP in blood samples
circulating markers of cardiovascular risk	10 years	Lipids, SuPAR in blood samples
Assessment of cortisol/cortisone	10 years	measured in urine and hair samples by LCMS/MS
Change in lean body mass	10 years	Estimated by dual x-ray absorptiometry at start, 1, 3, 5 and 10 years
Respiratory function	10 years	Forced Expiratory Volume in the first second and forced vital capacity estimated by spirometry at start, 1, 3, 5 and 10 years

Countries

Denmark

Contacts

Primary Contactmarianne andersen, Professor

msa@rsyd.dk+4565412502

Backup ContactLouise Christensen, MD

louise.lehmann.christensen@rsyd.dk+4565412502

Outcome results