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Extracellular Vesicles and Endothelial Function in Transgender Subjects

NCT ID: NCT04971447

Last Updated: 2022-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Transgenderism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group: transgender men

Group Type EXPERIMENTAL

gender affirming hormonal treatment in transgender men

Intervention Type DRUG

testosterone enanthate

Groupe: control cis-gender women

Group Type NO_INTERVENTION

No interventions assigned to this group

Group: transgender women

Group Type EXPERIMENTAL

gender affirming hormonal treatment in transgender women

Intervention Type DRUG

GnRH agonists + estrogen

Groupe: control cis-gender men

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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gender affirming hormonal treatment in transgender men

testosterone enanthate

Intervention Type DRUG

gender affirming hormonal treatment in transgender women

GnRH agonists + estrogen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Trasgender subject demanding gender affirming hormonal therapy

Exclusion Criteria

* Previous hormonal therapy
* Pregnancy
* Chronic disease
* Cancer
* Obesity
* Drug abuse
* Alcohol
* Tabac
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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21.03.30.69624

Identifier Type: -

Identifier Source: org_study_id

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