Gender DysphoriaGeDyParNCT04160364
Gender Dysphoria in Children and Adolescents : Parents' Perspectives
An observational study of Gender Dysphoria, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Gender dysphoria is defined as a persistent incongruence between an experienced gender and the assigned sex at birth Transgender and gender nonconforming persons desire to modify their appearance to be consistent with their self-identified gender identities. 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?
- qualitative study
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2020to Jan 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
- No healthy volunteers
- Adult, Older adult
Study population: The study will be proposed to parents of transgender children <18 years of age followed in the endocrinology, diabetology and nutrition department of the University Hospital of Nancy on the occasion of the regular follow-up visit at the outpatient clinic ( consecutive recruitment).
Who may be able to join
- be a parent of a child <18 years followed in the endocrinology department of the University Hospital of Nancy for gender dysphoria
- be in stable couple
- both parents agree to participate
- capacity to communicate in French
- Person who has received complete information on the organization of the research and who agreed to the exploitation of the data
Who cannot join
- Refusal to participate
- Inability to be physically, psychologically or linguistically involved in the study
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital of Nancy
Vandœuvre-lès-Nancy, 54511
Eva Feigerlova, MD, PhD, 00330670204634
About this study
Gender dysphoria is defined as a persistent incongruence between an experienced gender and the assigned sex at birth Transgender and gender nonconforming persons desire to modify their appearance to be consistent with their self-identified gender identities. In non-binary people, contrary to binary transgender persons, self-identified gender identities do not fit the classical pattern male/female.
During the last decennium, an increase in the number of young subjects, especially children and adolescents, referred to gender identity centres has been observed. A new nosological entity "rapid-onset gender dysphoria in adolescents and young adults" has recently been described in the literature, whose etiology has not been well understood.
This growing demand of adolescents and young adults observed in the recent years is not well understood.
- Conditions
- Gender Dysphoria
- Being tested
- qualitative study
- Keywords
- children, adolescents, parents
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qualitative studyOther
qualitative research via guided interview
What is being measured
The primary outcome is the main question the study is designed to answer.
thematic analysis
The recorde material will be coded using descriptive codes. Conceptual notes will be written, through processes of condensation, comparison and abstracting the initial notes.
Connections between notes will be noted and synthesized, and emergent themes will be developed.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study startOct 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJan 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.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Feigerlova, MD,PhD, Principal investigator, University Hospital of Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160364
- Sponsor's protocol ID
- 2019PI204
- Acronym
- GeDyPar
- Status last verified
- Jul 2020
- First submitted
- 8 Nov 2019
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planned
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Dysphoria in Children and Adolescents : Parents' Perspectives
- ClinicalTrials.gov ID
- NCT04160364
- Acronym / sponsor ID
- GeDyPar / 2019PI204
- Conditions
- Gender Dysphoria
- Keywords
- children, adolescents, parents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 13 Nov 2019 (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.
Gender dysphoria is defined as a persistent incongruence between an experienced gender and the assigned sex at birth Transgender and gender nonconforming persons desire to modify their appearance to be consistent with their self-identified gender identities. In non-binary people, contrary to binary transgender persons, self-identified gender identities do not fit the classical pattern male/female.
During the last decennium, an increase in the number of young subjects, especially children and adolescents, referred to gender identity centres has been observed. A new nosological entity "rapid-onset gender dysphoria in adolescents and young adults" has recently been described in the literature, whose etiology has not been well understood.
This growing demand of adolescents and young adults observed in the recent years is not well understood.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be proposed to parents of transgender children <18 years of age followed in the endocrinology, diabetology and nutrition department of the University Hospital of Nancy on the occasion of the regular follow-up visit at the outpatient clinic ( consecutive recruitment).
Key inclusion criteria (5 listed)
- be a parent of a child <18 years followed in the endocrinology department of the University Hospital of Nancy for gender dysphoria
- be in stable couple
- both parents agree to participate
- capacity to communicate in French
- Person who has received complete information on the organization of the research and who agreed to the exploitation of the data
Key exclusion criteria (2 listed)
- Refusal to participate
- Inability to be physically, psychologically or linguistically involved in the study
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 |
|---|---|---|
| qualitative studyqualitative research via guided interview | Other | – |
Primary outcome
thematic analysis
Time frame: one year
The recorde material will be coded using descriptive codes. Conceptual notes will be written, through processes of condensation, comparison and abstracting the initial notes. Connections between notes will be noted and synthesized, and emergent themes will be developed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Individual participant dataSharing planned: No. Not planned
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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.
Eva Feigerlova, MD,PhD principal investigator
University Hospital of Nancy, France
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 Gender Dysphoria, run by Central Hospital, Nancy, France 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 5 inclusion and 2 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 13 Aug 2020. 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?
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 (00330383153412, 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?
thematic analysis (time frame: one year). 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 13 Aug 2020.