Gender DysphoriaDyGePeTNCT04265885
Gender Dysphoria and Transition
An observational study of Gender Dysphoria, run by Central Hospital, Nancy, France.
Trial summary
Persons with gender dysphoria present the difficulties of access to health care. Little time is devoted to education of health professionals about the care of transgender persons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gender Dysphoria
- What is being tested?
- collection of testimonies from transgender people
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Sep 2021
- 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
- Adult, Older adult
Study population: The participation to the study will be offered consecutively to adult subjects with gender dysphoria followed in the department of endocrinology, diabetology and nutrition of the University Hospital of Nancy.
Who may be able to join
- Person affiliated to a social security system
- Person having received complete information on the organisation of the research and having signed the informed consent
- Person having carried out a prior clinical examination adapted to the research
- Age> 18 years
- Diagnosis of gender incongruence (dysphoria) according to the international classification of diseases, revision 11
Who cannot join
- Severe, uncontrolled psychiatric or somatic illness
- Substance and alcohol addiction
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Gender Dysphoria and Transition: Testimony From Transgender People
Persons with gender dysphoria present the difficulties of access to health care. Little time is devoted to education of health professionals about the care of transgender persons. According to the proposal of the French Ministry of Social Affairs and Health there is a need to increase knowledge in this area and to improve the care of transgender people including prevention and screening.
Similarly, little is known about social and medical needs of the transgender population.
This project proposes to illustrate gender dysphoria through testimonies of transgender people with the aim to increase the investigator's understanding aout the needs and the desires of this population and to describe the process of medical and social transition.
- Conditions
- Gender Dysphoria
- Being tested
- collection of testimonies from transgender people
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of testimonies from transgender peopleOther
guided interview
What is being measured
The primary outcome is the main question the study is designed to answer.
Illustrate the real-life experiences of transgender people
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study startOct 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- 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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lorraine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265885
- Sponsor's protocol ID
- 2020PI033
- Acronym
- DyGePeT
- Status last verified
- Jul 2020
- First submitted
- 10 Feb 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Dysphoria and Transition: Testimony From Transgender People
- ClinicalTrials.gov ID
- NCT04265885
- Acronym / sponsor ID
- DyGePeT / 2020PI033
- Conditions
- Gender Dysphoria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University of Lorraine
- Study start
- Oct 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 12 Feb 2020 (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.
Persons with gender dysphoria present the difficulties of access to health care. Little time is devoted to education of health professionals about the care of transgender persons. According to the proposal of the French Ministry of Social Affairs and Health there is a need to increase knowledge in this area and to improve the care of transgender people including prevention and screening.
Similarly, little is known about social and medical needs of the transgender population.
This project proposes to illustrate gender dysphoria through testimonies of transgender people with the aim to increase the investigator's understanding aout the needs and the desires of this population and to describe the process of medical and social transition.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The participation to the study will be offered consecutively to adult subjects with gender dysphoria followed in the department of endocrinology, diabetology and nutrition of the University Hospital of Nancy.
Key inclusion criteria (5 listed)
- Person affiliated to a social security system
- Person having received complete information on the organisation of the research and having signed the informed consent
- Person having carried out a prior clinical examination adapted to the research
- Age> 18 years
- Diagnosis of gender incongruence (dysphoria) according to the international classification of diseases, revision 11
Key exclusion criteria (3 listed)
- Severe, uncontrolled psychiatric or somatic illness
- Substance and alcohol addiction
- Pregnancy
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 |
|---|---|---|
| collection of testimonies from transgender peopleguided interview | Other | – |
Primary outcome
Illustrate the real-life experiences of transgender people
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Dysphoria, run by Central Hospital, Nancy, 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Feigerlova, MD, PhD (+33(0)83155032, e.feigerlova@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illustrate the real-life experiences of transgender people (time frame: 4 months). 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 11 Aug 2020.