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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05761678
Other study ID # 2021-A03156-35
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 21, 2023
Est. completion date February 21, 2026

Study information

Verified date February 2023
Source Ramsay Générale de Santé
Contact Jean-François Oudet
Phone 0683346567
Email jf.oudet@ecten.eu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Transgender people have an identity or an expression gender that differs from the sex assigned to them at the birth. Transgender people and their needs remain misunderstood, and more generally by society. THE transgender populations express poor quality of life compared to the general population. However, very few of studies are interested in these people, in their diversity of paths, trajectories and characteristics of life. More of research is needed to study the quality of life, understand the experiences, in their diversity and in the health, social and life trajectories. Researches must be carried out, in particular on how to interrogate by the seeks out transgender people, in order to prevent stigmatization within population studies. The main objective of this study is to assess the quality of life of people transgender people during their life trajectory and their transition path, based on validated questionnaires scientifically in French, for major themes of the population concerned (quality of life, social support perceived).


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date February 21, 2026
Est. primary completion date August 21, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Transgender people (having a gender identity or expression that differs from the sex assigned to them at birth); - People with any of the following characteristics regarding their trans identity: - Consultant in one of the transgender reference centers and services for questions/information on the transition; - Integrated or having completed a course of care with or without gender reassignment surgery; - Not integrated into a health or care pathway. - French-speaking people; - Adults; - People able to use the tools digital; - People with Internet or 4G access (total or limited) Exclusion Criteria: - People who do not identify as transgender; - Non-French speaking people; - Minors - People who do not know how to handle the tools digital data collection; - People without Internet access. - Non-French speaking people, unable to speak understand the research questions - Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by court order or administrative

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire quality of life
Quantitative - Validated online self-questionnaires scientifically to assess quality of life and support perceived social. Items created for the study concerning socio-demographic characteristics and satisfaction of health services concerning the accompaniment of the transidentity. Qualitative - Semi-structured interviews based on a guide maintenance.

Locations

Country Name City State
France Hôpital privé Jean Mermoz Lyon

Sponsors (1)

Lead Sponsor Collaborator
Ramsay Générale de Santé

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life estimated with a validated questionnaire administered over the Internet repeatedly every three months. Quality of life estimated with a validated questionnaire administered over the Internet repeatedly every three months. 3 months
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