Transgender Men, Non-binary Persons and Testosterone Trea... | NCT04254354

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

NCT04254354

Sponsor

Marianne Andersen

Status

Recruiting

Last Update Posted

Aug 13, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Transgenderism

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2020Actual

Primary Completion Date

Jan 1, 2044Estimated

Completion Date

Jan 1, 2044Estimated

First Submitted Date

Jan 21, 2020

First Submission Date that Met QC Criteria

Feb 2, 2020

First Posted Date

Feb 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2025

Last Update Posted Date

Aug 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Label	Type	Description	Intervention Names
transgender men		no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Calcium score	CCTA	10 years
Change in muscle strength and power	Estimated by low row and accelometer at start, 1, 3, 5, 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Transgender men

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Persons assigned female at birth (+18 years) that either use or want to use testosterone with the purpose of undergoing gender transformation. -

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
marianne andersen, Professor	Contact	+4565412502		msa@rsyd.dk
Louise Christensen, MD	Contact	+4565412502		louise.lehmann.christensen@rsyd.dk

Overall Officials

Name	Affiliation	Role
Marianne Andersen	Odense University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital	Recruiting	Odense		5000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33376186	Derived	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.

ID	Term
D019529	Sexuality
D012725	Sexual Behavior
D001519	Behavior