Evinge: Extracellular Vesicles and Endothelial Function in Transgender Subjects

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04971447

Collaborator

(none)

136

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Transgenderism	Drug: gender affirming hormonal treatment in transgender men Drug: gender affirming hormonal treatment in transgender women	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

136 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Plasma Extracellular Vesicles on Endothelial Function in Transgender Subjects

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group: transgender men	Drug: gender affirming hormonal treatment in transgender men testosterone enanthate
No Intervention: Groupe: control cis-gender women
Experimental: Group: transgender women	Drug: gender affirming hormonal treatment in transgender women GnRH agonists + estrogen
No Intervention: Groupe: control cis-gender men

Outcome Measures

Primary Outcome Measures

pulse wave velocity [24 months]
measurement of arterial stiffness

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Trasgender subject demanding gender affirming hormonal therapy

Exclusion Criteria:

Previous hormonal therapy
Pregnancy
Chronic disease
Cancer
Obesity
Drug abuse
Alcohol
Tabac

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT04971447

Other Study ID Numbers:

21.03.30.69624

First Posted:

Jul 21, 2021

Last Update Posted:

Jul 25, 2022

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Central Hospital, Nancy, France

transgender persons

hormonal therapy

Study Results

No Results Posted as of Jul 25, 2022