Odense University Hospital
Odense, 5000, Denmark
Location status: Recruiting
Recruiting
NCT Number: NCT04254354
Transgender Men, Non-binary Persons and Testosterone Treatment BODY IDENTITY CLINIC
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Transgender men
Exclusion criteria
none
Treatment and study plan
Primary outcomes
-
Effect of testosterone on devellopment of plaques in the heart
Time frame: 10 years
Estimated directly by CCTA, at start, (1 year for early included participants) 5 and 10 years
Secondary outcomes
-
Calcium score
Time frame: 10 years
CCTA
-
Change in muscle strength and power
Time frame: 10 years
Estimated by low row and accelometer at start, 1, 3, 5, 10 years
-
Effect of transgender treatment on quality of life
Time frame: 10 years
Estimated by quality of life questionnaire (SF36) at start, 1, 3, 5 and 10 years
-
Effect of transgender treatment on aggression
Time frame: 10 years
Estimated by aggression questionnaire at start, 1, 3, 5 and 10 years
-
Changes in maximal oxygen consumption during transgender treatment
Time frame: 10 years
Estimated by test og maximal oxygen consumption (vo2max) at start, 1, 3, 5 and 10 years
-
Heart function
Time frame: 10 years
Ejection fraction and left ventricular muscle mass are measured by echocardiography at start,(1 for early included participants) 5 and 10 years
-
Respiratory function
Time frame: 10 years
Forced Expiratory Volume in the first second and forced vital capacity estimated by spirometry at start, 1, 3, 5 and 10 years
-
Levels of testosterone, estradiol and cortisol
Time frame: 10 years
Measured in serum by LCMS/MS
-
circulating markers of inflammation
Time frame: 10 years
CRP in blood samples
-
circulating markers of cardiovascular risk
Time frame: 10 years
Lipids, SuPAR in blood samples
-
Assessment of cortisol/cortisone
Time frame: 10 years
measured in urine and hair samples by LCMS/MS
-
Change in lean body mass
Time frame: 10 years
Estimated by dual x-ray absorptiometry at start, 1, 3, 5 and 10 years
Study contacts
Contact information is provided by the study sponsor or research team.
Louise Christensen, MD
CONTACT
marianne andersen, Professor
CONTACT
Sponsors and collaborators
Lead sponsor
Marianne Andersen
Other
Registry information
Official study title
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)
Important dates
- Study start
- 2020
- Primary completion
- 2044
- Study completion
- 2044
- First posted
- Feb 5, 2020
- Registry last updated
- Aug 13, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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