Extracellular Vesicles and Endothelial Function in Transgender Subjects (Evinge)

Central Hospital, Nancy, France

Status: Unknown

Conditions: Transgenderism

Treatments: Drug: gender affirming hormonal treatment in transgender men; Drug: gender affirming hormonal treatment in transgender women

Study type: Interventional

Funder types: Other

Identifiers

NCT04971447

21.03.30.69624

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 49 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

136 participants in 4 patient groups

Group: transgender men

Experimental group

Treatment:

Drug: gender affirming hormonal treatment in transgender men

Groupe: control cis-gender women

No Intervention group

Group: transgender women

Experimental group

Treatment:

Drug: gender affirming hormonal treatment in transgender women

Groupe: control cis-gender men

No Intervention group