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

  • End date
    Jan 1, 2044
  • participants needed
  • sponsor
    Marianne Andersen
Updated on 28 February 2022
Accepts healthy volunteers


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


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.

Condition Transgenderism
Treatment No intervention
Clinical Study IdentifierNCT04254354
SponsorMarianne Andersen
Last Modified on28 February 2022


Yes No Not Sure

Inclusion Criteria

Transgender men

Exclusion Criteria

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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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