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)
Led by Marianne Andersen · Updated on 2025-08-13
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What this Trial Is About
This research aims to study transgender men and non-binary persons before and during testosterone treatment. It focuses on understanding how testosterone affects cardiovascular health, muscle strength and power, aggression, quality of life, as well as cardiac and respiratory function. The study observes these effects over an extended period to provide insights into the short- and long-term impact of masculinizing treatment.
The study is a prospective, single-center observational cohort conducted at the Body Identity Clinic, where participants undergo assessments at the start and after 1, 3, 5, and 10 years of testosterone therapy. There is no intervention administered by the study team, as it observes participants receiving testosterone treatment as part of their gender-affirming care.
Participants will be evaluated through various tests and questionnaires at multiple time points over 10 years. These include measurements of heart plaque development, calcium scores, muscle strength and power, oxygen consumption, hormone levels, inflammation markers, cardiovascular risk indicators, and assessments of aggression, quality of life, heart, and respiratory function. All findings will be used to better understand the effects of testosterone treatment in this population.
CONDITIONS
Brief Title
Transgender Men, Non-binary Persons and Testosterone Treatment BODY IDENTITY CLINIC
Who Can Participate
Age: 18Years +
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Identify as a transgender man
Age 18 years or older
You will not qualify if you...
History of severe allergic reactions to study medication
Currently pregnant or breastfeeding
Recent participation in another clinical trial within the last 30 days
Presence of uncontrolled medical conditions that could affect safety
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - At baseline
Participants undergo initial evaluations including assessments of cardiovascular, muscle strength, respiratory function, hormone levels, and inflammatory markers at the start of testosterone therapy.
1 baseline visit (in-person)
Long-term Monitoring
Duration - 10 years
Participants are observed over 10 years with repeated assessments to monitor effects of testosterone treatment on cardiovascular health, muscle strength, respiratory function, hormone levels, and quality of life.
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).
Louise Lehmann Christensen, Dorte Glintborg, Tine Taulbjerg Kristensen...