Transgender Management CareGyneTransNCT06357130
Gynaecological Care for Transgender People in France in 2024.
An observational study of Transgender Management Care, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transgender Management Care
- What is being tested?
- Questionnaire
- How many people
- 246 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2024to 16 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- French-speaking transgender person (transgender women or transgender men)
- age ≥18 years
Who cannot join
- age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The hypothesis of this study is that transgender population in France does not have appropriate gynecological care, and the study would like to find out, directly from the people concerned, the current state of gynecological care for transgender people in France. To do this, ths study plan to send out a questionnaire to transgender people (via healthcare networks and also transgender associations) to ask them about their actual gynecological care and their knowledge of recommended gynecological care.
The aim is to set up a descriptive, declarative study based on a questionnaire created specifically for this work.
This project will use a questionnaire for transwomen people and another one for transmen people. Transgender people will be approached via Trans associations and healthcare networks. An online link to the questionnaire will be sent to trans associations and healthcare networks for distribution to the target population thanks to a flyer.
- Conditions
- Transgender Management Care
- Being tested
- Questionnaire
- Keywords
- Gynaecology, Gender-affirming hormonal therapy, Breast Cancer, Transgender, Contraception
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Transgender | Transgender population in France, male to female and female to male. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of people aware of gynaecological recommendations.
Percentage of transgender people who know regular gynaecological recommendations in France, thanks to a homemade questionnaire
Measured: 24 months after inclusion day
Secondary outcomes (4)
Percentage of people aware of cancer risks
Overview of organized screening for gynaecological cancers and prostate cancer in the transgender population, thanks to a homemade questionnaire
Measured: 24 months after inclusion day
Percentage of people aware of contraception in transgender male population
Overview of knowledge about contraception in the transgender male population,thanks to a homemade questionnaire.
Measured: 24 months after inclusion day
Percentage of people aware of fertility and the impact of hormone treatments
Overview of knowledge about fertility and the impact of hormone treatments in the transgender population, thanks to a homemade questionnaire.
Measured: 24 months after inclusion day
Percentage of people aware of gynaecological repercussions of masculinizing hormone treatment in transgender male population
Overview of our knowledge of the gynaecological repercussions of masculinizing hormone treatment in the transgender male population, thanks to a homemade questionnaire.
Measured: 24 months after inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start3 Jun 2024
- Primary completion16 Jun 2026
- Study completion16 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transgender Management CareStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357130
- Sponsor's protocol ID
- CHUBX 2023/75
- Acronym
- GyneTrans
- Status last verified
- Jun 2026
- First submitted
- 4 Apr 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gynaecological Care for Transgender People in France in 2024.
- ClinicalTrials.gov ID
- NCT06357130
- Acronym / sponsor ID
- GyneTrans / CHUBX 2023/75
- Conditions
- Transgender Management Care
- Keywords
- Gynaecology, Gender-affirming hormonal therapy, Breast Cancer, Transgender, Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The hypothesis of this study is that transgender population in France does not have appropriate gynecological care, and the study would like to find out, directly from the people concerned, the current state of gynecological care for transgender people in France. To do this, ths study plan to send out a questionnaire to transgender people (via healthcare networks and also transgender associations) to ask them about their actual gynecological care and their knowledge of recommended gynecological care.
The aim is to set up a descriptive, declarative study based on a questionnaire created specifically for this work.
This project will use a questionnaire for transwomen people and another one for transmen people. Transgender people will be approached via Trans associations and healthcare networks. An online link to the questionnaire will be sent to trans associations and healthcare networks for distribution to the target population thanks to a flyer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transgender | – | Other: QuestionnaireTransgender population in France, male to female and female to male. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- French-speaking transgender person (transgender women or transgender men)
- age ≥18 years
Key exclusion criteria (1 listed)
- age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireA flyer with QR code leading to the online questionnaire will be sent to trans associations and healthcare networks for distribution to the target population. | Other | Transgender |
Primary outcome
Percentage of people aware of gynaecological recommendations.
Time frame: 24 months after inclusion day
Percentage of transgender people who know regular gynaecological recommendations in France, thanks to a homemade questionnaire
4 secondary outcomes
Percentage of people aware of cancer risks
Time frame: 24 months after inclusion day
Percentage of people aware of contraception in transgender male population
Time frame: 24 months after inclusion day
Percentage of people aware of fertility and the impact of hormone treatments
Time frame: 24 months after inclusion day
Percentage of people aware of gynaecological repercussions of masculinizing hormone treatment in transgender male population
Time frame: 24 months after inclusion day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgender Management Care, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of people aware of gynaecological recommendations. (time frame: 24 months after inclusion day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.