Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
ID04254354

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

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

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

Eligible

You may qualify if you...

  • Identify as a transgender man
  • Age 18 years or older
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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.

Visits at 1, 3, 5 and 10 years (in-person)

Trial Site Locations

Total: 1 location

1

Odense University Hospital

Odense, Denmark, 5000

Actively Recruiting

Loading map...

Research Team

M

marianne andersen, Professor

L

Louise Christensen, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

Androgen Effects on the Reproductive Neuroendocrine Axis, 20...

Transgenderism

Actively Recruiting

1 location

Investigation of the Effects of Testosterone and Estrogen on...

Transsexualism

Actively Recruiting

1 location

Epithesis Versus Prosthesis in Post-phalloplasty Transgender...

Transgenderism

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

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...

https://pubmed.ncbi.nlm.nih.gov/33376186