An observational study in Transgenderism, sponsored by Marianne Andersen. Recruiting at 1 site in Denmark. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by Marianne Andersen · Observational
The aim of this study is to investigate transgender men and non-binary persons before and during testosterone treatment. The study will focus on:
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.
Marianne Andersen is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Persons assigned female at birth (+18 years) that either use or want to use testosterone with the purpose of undergoing gender transformation. -
Transgender men
Exclusion Criteria:
none
no intervention
Effect of testosterone on devellopment of plaques in the heart
Estimated directly by CCTA, at start, (1 year for early included participants) 5 and 10 years
Time frame: 10 years
Calcium score
CCTA
Time frame: 10 years
Change in muscle strength and power
Estimated by low row and accelometer at start, 1, 3, 5, 10 years
Time frame: 10 years
Effect of transgender treatment on quality of life
Estimated by quality of life questionnaire (SF36) at start, 1, 3, 5 and 10 years
Time frame: 10 years
Effect of transgender treatment on aggression
Estimated by aggression questionnaire at start, 1, 3, 5 and 10 years
Time frame: 10 years
Changes in maximal oxygen consumption during transgender treatment
Estimated by test og maximal oxygen consumption (vo2max) at start, 1, 3, 5 and 10 years
Time frame: 10 years
Heart function
Ejection fraction and left ventricular muscle mass are measured by echocardiography at start,(1 for early included participants) 5 and 10 years
Time frame: 10 years
Respiratory function
Forced Expiratory Volume in the first second and forced vital capacity estimated by spirometry at start, 1, 3, 5 and 10 years
Time frame: 10 years
Levels of testosterone, estradiol and cortisol
Measured in serum by LCMS/MS
Time frame: 10 years
circulating markers of inflammation
CRP in blood samples
Time frame: 10 years
circulating markers of cardiovascular risk
Lipids, SuPAR in blood samples
Time frame: 10 years
Assessment of cortisol/cortisone
measured in urine and hair samples by LCMS/MS
Time frame: 10 years
Change in lean body mass
Estimated by dual x-ray absorptiometry at start, 1, 3, 5 and 10 years
Time frame: 10 years
Plan to share: Undecided
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Transsexualism
Marianne Andersen