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

Transgenderism Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04254354
• Other study ID #: BICTX01
• Status: Recruiting
• Start date: March 3, 2020
• Est. completion date: January 1, 2044

Study information

• Verified date: June 2024
• Source: Odense University Hospital
• Contact: marianne andersen, Professor
• Phone: +4565412502
• Email: msa[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 1, 2044
• Est. primary completion date: January 1, 2044
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Transgender men

Exclusion Criteria:

none

Related Conditions & MeSH terms

• Transgenderism

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Marianne Andersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Calcium score	CCTA	10 years
Secondary	Change in muscle strength and power	Estimated by low row and accelometer at start, 1, 3, 5, 10 years	10 years
Secondary	Effect of transgender treatment on quality of life	Estimated by quality of life questionnaire (SF36) at start, 1, 3, 5 and 10 years	10 years
Secondary	Effect of transgender treatment on aggression	Estimated by aggression questionnaire at start, 1, 3, 5 and 10 years	10 years
Secondary	Changes in maximal oxygen consumption during transgender treatment	Estimated by test og maximal oxygen consumption (vo2max) at start, 1, 3, 5 and 10 years	10 years
Secondary	Heart function	Ejection fraction and left ventricular muscle mass are measured by echocardiography at start,(1 for early included participants) 5 and 10 years	10 years
Secondary	Respiratory function	Forced Expiratory Volume in the first second and forced vital capacity estimated by spirometry at start, 1, 3, 5 and 10 years	10 years
Secondary	Levels of testosterone, estradiol and cortisol	Measured in serum by LCMS/MS	10 years
Secondary	circulating markers of inflammation	CRP in blood samples	10 years
Secondary	circulating markers of cardiovascular risk	Lipids, SuPAR in blood samples	10 years
Secondary	Assessment of cortisol/cortisone	measured in urine and hair samples by LCMS/MS	10 years
Secondary	Change in lean body mass	Estimated by dual x-ray absorptiometry at start, 1, 3, 5 and 10 years	10 years