NCT04971447

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2021

Enrollment Period

1.1 years

First QC Date

July 12, 2021

Last Update Submit

July 22, 2022

Conditions

Transgenderism

Keywords

transgender personshormonal therapy

Outcome Measures

Primary Outcomes (1)

  • pulse wave velocity

    measurement of arterial stiffness

    24 months

Study Arms (4)

Group: transgender men

EXPERIMENTAL
Drug: gender affirming hormonal treatment in transgender men

Groupe: control cis-gender women

NO INTERVENTION

Group: transgender women

EXPERIMENTAL
Drug: gender affirming hormonal treatment in transgender women

Groupe: control cis-gender men

NO INTERVENTION

Interventions

gender affirming hormonal treatment in transgender menDRUG

testosterone enanthate

Group: transgender men
gender affirming hormonal treatment in transgender womenDRUG

GnRH agonists + estrogen

Group: transgender women

Eligibility Criteria

Age18 Years - 49 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsyes
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Trasgender subject demanding gender affirming hormonal therapy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Transsexualism

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2021

First Posted

July 21, 2021

Study Start

August 1, 2022

Primary Completion

September 1, 2023

Study Completion

January 1, 2024

Last Updated

July 25, 2022

Record last verified: 2021-07