Extracellular Vesicles and Endothelial Function in Transgender Subjects (Evinge)

July 22, 2022 updated by: Central Hospital, Nancy, France

Effects of Plasma Extracellular Vesicles on Endothelial Function in Transgender Subjects

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Trasgender subject demanding gender affirming hormonal therapy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulse wave velocity
Time Frame: 24 months
measurement of arterial stiffness
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21.03.30.69624

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Transgenderism

Clinical Trials on gender affirming hormonal treatment in transgender men

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe