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NCT05169762 Clinical Trial

Feminizing Treatment in Transgender Women and Non-binary Persons

Transgenderism Clinical Trial

— BIC-Estrogen  

Official title:
Feminizing Treatment in Transgender Women and Non-binary Persons BODY IDENTITY CLINIC - ESTROGEN

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05169762
Other study ID # BICTX03
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date September 1, 2035

Study information
Verified date November 2022
Source Odense University Hospital
Contact Dorte Glintborg
Phone +4565411807
Email dorte.glintborg@rsyd.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cohort study in 100 transgender women treated with gender affirming hormone treatment. Follow up affter 1year, 3 years, 5 years and 10 years, Outcomes regarding cardiovascular effects of hormone treatment.

Description:

Cohort study in 100 transgender women treated with gender affirming hormone treatment. Follow up affter 1year, 3 years, 5 years and 10 years, Outcomes: Non-calcified and calcified plaque formation by contras coronary CT angiograms Heartfunction by ekko Cardiovaskular risk markers, f. eks. bp Markers of cardiovascular risk in blood and urine

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date September 1, 2035
Est. primary completion date September 1, 2035
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - assigned male at birth and eligeble for gender affirming feminizing treatment Exclusion Criteria: none -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• standard treatment
starndard treatment for transgender women

Locations
Country Name City State
Denmark OdenseUH Odense

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary coronary plaque formation mm3 1 year
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