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)
1 other identifier
observational
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
March 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2044
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2044
August 13, 2025
August 1, 2025
23.8 years
January 21, 2020
August 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
10 years
Secondary Outcomes (12)
Calcium score
10 years
Change in muscle strength and power
10 years
Effect of transgender treatment on quality of life
10 years
Effect of transgender treatment on aggression
10 years
Changes in maximal oxygen consumption during transgender treatment
10 years
- +7 more secondary outcomes
Study Arms (1)
transgender men
no intervention
Eligibility Criteria
Persons assigned female at birth (+18 years) that either use or want to use testosterone with the purpose of undergoing gender transformation. -
You may qualify if:
- Transgender men
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Odense University Hospital
Odense, 5000, Denmark
Related Publications (1)
Lehmann Christensen L, Glintborg D, Taulbjerg Kristensen T, Diederichsen A, T'Sjoen G, Frystyk J, Skovsager Andersen M. Masculinising testosterone treatment and effects on preclinical cardiovascular disease, muscle strength and power, aggression, physical fitness and respiratory function in transgender men: protocol for a 10-year, prospective, observational cohort study in Denmark at the Body Identity Clinic (BIC). BMJ Open. 2020 Dec 29;10(12):e045714. doi: 10.1136/bmjopen-2020-045714.
PMID: 33376186DERIVED
Biospecimen
blood, urine, hair
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marianne Andersen
Odense University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 21, 2020
First Posted
February 5, 2020
Study Start
March 3, 2020
Primary Completion (Estimated)
January 1, 2044
Study Completion (Estimated)
January 1, 2044
Last Updated
August 13, 2025
Record last verified: 2025-08