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

Sponsor
Marianne Andersen (Other)
Overall Status
Recruiting
CT.gov ID
NCT04254354
Collaborator
(none)
200
Enrollment
1
Location
286
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official 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)
    Actual Study Start Date :
    Mar 3, 2020
    Anticipated Primary Completion Date :
    Jan 1, 2044
    Anticipated Study Completion Date :
    Jan 1, 2044

    Arms and Interventions

    Arm Intervention/Treatment
    transgender men

    no intervention

    Outcome Measures

    Primary Outcome Measures

    1. Effect of testosterone on devellopment of plaques in the heart [10 years]

      Estimated directly by CCTA, at start, 1 year and 10 years

    Secondary Outcome Measures

    1. Calcium score [10 years]

      CCTA

    2. Change in muscle strength and power [10 years]

      Estimated by low row and accelometer at start, 1, 3, 5, 10 years

    3. 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

    4. Effect of transgender treatment on aggression [10 years]

      Estimated by aggression questionnaire at start, 1, 3, 5 and 10 years

    5. 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

    6. Heart function [10 years]

      Ejection fraction and left ventricular muscle mass are measured by echocardiography at start, 1, 3, 5 and 10 years

    7. 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

    8. Levels of testosterone, estradiol and cortisol [10 years]

      Measured in serum by LCMS/MS

    9. circulating markers of inflammation [10 years]

      CRP in blood samples

    10. circulating markers of cardiovascular risk [10 years]

      Lipids, SuPAR in blood samples

    11. Assessment of cortisol/cortisone [10 years]

      measured in urine and hair samples by LCMS/MS

    12. Change in lean body mass [10 years]

      Estimated by dual x-ray absorptiometry at start, 1, 3, 5 and 10 years

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Transgender men

    Exclusion Criteria:

    none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Odense University Hospital Odense Denmark 5000

    Sponsors and Collaborators

    • Marianne Andersen

    Investigators

    • Principal Investigator: Marianne Andersen, Odense University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marianne Andersen, Professor, Odense University Hospital
    ClinicalTrials.gov Identifier:
    NCT04254354
    Other Study ID Numbers:
    • BICTX01
    First Posted:
    Feb 5, 2020
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 8, 2021