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NCT04971447 Clinical Trial

Extracellular Vesicles and Endothelial Function in Transgender Subjects

Transgenderism Clinical Trial

— Evinge  

Official title:
Effects of Plasma Extracellular Vesicles on Endothelial Function in Transgender Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04971447
Other study ID # 21.03.30.69624
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2022
Est. completion date January 2024

Study information
Verified date July 2021
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cardiovascular diseases are the leading cause of mortality. In women, the prevalence of cardiovascular diseases is lower and the presentation of coronary events often atypical. The lack of evidence is related in part to the methodology of studies not considering sex as an essential biological variable. Hormonal treatment is prescribed in transgender subjects to promote the development of sexual characteristics of the desired sex. Early cardiovascular effects of hormonal treatment have been reported in transgender men, while long-term mortality is higher in transgender women. The aim of this project is to study the effects of gender affirming hormonal treatment on arterial stiffness in young transgender subjects followed at the University Hospital of Nancy.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 136
Est. completion date January 2024
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: - Trasgender subject demanding gender affirming hormonal therapy Exclusion Criteria: - Previous hormonal therapy - Pregnancy - Chronic disease - Cancer - Obesity - Drug abuse - Alcohol - Tabac

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• gender affirming hormonal treatment in transgender men
testosterone enanthate
• gender affirming hormonal treatment in transgender women
GnRH agonists + estrogen

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome
Type Measure Description Time frame Safety issue
Primary pulse wave velocity measurement of arterial stiffness 24 months
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