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

NCT ID: NCT04254354

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-03

Study Completion Date

2044-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Transgenderism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

transgender men

no intervention

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Transgender men

Exclusion Criteria

none
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Marianne Andersen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marianne Andersen

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marianne Andersen

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

marianne andersen, Professor

Role: CONTACT

+4565412502

Louise Christensen, MD

Role: CONTACT

+4565412502

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mariannne S Andersen, Prof

Role: primary

+4565412502

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33376186 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BICTX01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hormone Secretion in Transgender Males
NCT04321551 WITHDRAWN PHASE4
Cycled Testosterone Replacement Study
NCT00957528 COMPLETED PHASE1
Oral T7 Oral Testosterone in Man
NCT00842751 COMPLETED PHASE2