Extracellular Vesicles and 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.

Full Title of Study: “Effects of Plasma Extracellular Vesicles on Endothelial Function in Transgender Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2023


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

Arms, Groups and Cohorts

  • Experimental: Group: transgender men
  • No Intervention: Groupe: control cis-gender women
  • Experimental: Group: transgender women
  • No Intervention: Groupe: control cis-gender men

Clinical Trial Outcome Measures

Primary Measures

  • pulse wave velocity
    • Time Frame: 24 months
    • measurement of arterial stiffness

Participating in This Clinical Trial

Inclusion Criteria

  • Trasgender subject demanding gender affirming hormonal therapy Exclusion Criteria:

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

Gender Eligibility: All


Minimum Age: 18 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Central Hospital, Nancy, France
  • Provider of Information About this Clinical Study
    • Sponsor

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