NCT06357130

Brief Summary

To date, the transgender population, still poorly characterized, tends to increase. The impact of gender-affirming hormone therapy (GAHT) in this population remains poorly understood, and few data are published on the gynecological repercussions of such therapy. A recent literature review by a French team suggests gynecological follow-up procedures for transgender people.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
246

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 3, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2026

Completed
Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

April 4, 2024

Last Update Submit

June 26, 2026

Conditions

Keywords

GynaecologyGender-affirming hormonal therapyBreast CancerTransgenderContraception

Outcome Measures

Primary Outcomes (1)

  • Percentage of people aware of gynaecological recommendations.

    Percentage of transgender people who know regular gynaecological recommendations in France, thanks to a homemade questionnaire

    24 months after inclusion day

Secondary Outcomes (4)

  • Percentage of people aware of cancer risks

    24 months after inclusion day

  • Percentage of people aware of contraception in transgender male population

    24 months after inclusion day

  • Percentage of people aware of fertility and the impact of hormone treatments

    24 months after inclusion day

  • Percentage of people aware of gynaecological repercussions of masculinizing hormone treatment in transgender male population

    24 months after inclusion day

Study Arms (1)

Transgender

Transgender population in France, male to female and female to male.

Other: Questionnaire

Interventions

A flyer with QR code leading to the online questionnaire will be sent to trans associations and healthcare networks for distribution to the target population.

Transgender

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Transgender people (male and female) will be approached via Trans associations (face-to-face and online) and the care networks in place at national level. An online link for completing the questionnaire will be sent to trans associations and healthcare networks for distribution to the target population via a paper or digital flyer.

You may qualify if:

  • French-speaking transgender person (transgender women or transgender men)
  • age ≥18 years

You may not qualify if:

  • age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Haut-Lévêque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 10, 2024

Study Start

June 3, 2024

Primary Completion

June 16, 2026

Study Completion

June 16, 2026

Last Updated

June 30, 2026

Record last verified: 2026-06

Locations