Investigating testosterone treatment effects in transgender men and non-binary individuals
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)
Run by Odense University Hospital · NCT04254354 · Data updated 2026-11-12
This study is testing how testosterone treatment affects the health and well-being of transgender men and non-binary individuals over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 1 site (Odense) |
| Status | Recruiting |
| Started | March 3, 2020 |
| Main results expected | January 1, 2044 |
| Study ends | January 1, 2044 |
| Registry record updated | August 13, 2025 |
| Trial ID | NCT04254354 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are transgender men and non-binary persons seeking testosterone treatment.
✕Probably not a fit
Patients who are not transgender men or non-binary individuals may not receive any benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the effects of testosterone treatment on transgender men and non-binary persons, focusing on various health aspects such as cardiovascular status, muscle strength, aggression, and quality of life. Conducted at the Body Identity Clinic in Denmark, participants will be monitored before and during testosterone therapy over a period of up to ten years. The study seeks to understand the potential development of non-calcified coronary plaque associated with testosterone treatment, contributing to the ongoing discussion about its short- and long-term effects.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the health impacts of testosterone treatment, guiding safer and more effective care for transgender individuals.
How similar studies have gone: While there is ongoing research in this area, the specific focus on cardiovascular effects and non-calcified coronary plaque in this population is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Transgender men Exclusion Criteria: none
Where it's running
-
Odense University Hospital
Odense, Denmark Recruiting
Study contacts
- Principal investigator: Marianne Andersen — Odense University Hospital
- Study coordinator: marianne andersen, Professor
- Email: msa@rsyd.dk
- Phone: +4565412502
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Effects of cross-sex hormone therapy on metabolism and eating behavior
This study looks at how cross-sex hormone therapy affects metabolism, eating habits, and overall health in people undergoing this treatment.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.