TransgenderismNCT05474768
Expectations and Beliefs of Transgender People Regarding Hormonal Treatment
An observational study of Transgenderism, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Hormonal treatment of gender dysphoria can have repercussions on metabolism, cardiovascular system and fertility and represents à potential oncological risk. According to the recommendations of the Endocrine society. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Transgenderism
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2022to Jan 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults with gender dysphoria and parent of adolescent/child presenting gender dysphoria, who are followed un the university hospital of Nancy
Who may be able to join
- being a parent of adolescent/child presenting Gender dysphoria
- adult subject (age > 18 years) presenting Gender dysphoria
- non-inclusion criteria
- Severe, uncontrolled psychiatric or somatic illness
- Chronic alcoholism
- Substance abuse
- Refusal or linguistic, physical or psychological incapacity to participate in the study
- Ongoing pregnancy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy
Nancy
Eva Feigerlova, 33 (0)3 83 15 34 12, e.feigerlova@chru-nancy.Fr
About this study
Hormonal treatment of gender dysphoria can have repercussions on metabolism, cardiovascular system and fertility and represents à potential oncological risk. According to the recommendations of the Endocrine society. Therefore, initial assessment and follow-up visits are necessary and must be carried out to avoid the apparition of potentially undesirable effects.
- Conditions
- Transgenderism
- Being tested
- no intervention
- Medical subject headings
- Transsexualism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe expectations and beliefs of transgener people about hormonal therapy
qualitative analysis of qualitative data from collective discussions (focus groups)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start2 Feb 2022
- Primary completionNov 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderismStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EVA FEIGERLOVA, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474768
- Sponsor's protocol ID
- 2021PI221
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expectations and Beliefs of Transgender People Regarding Hormonal Treatment
- ClinicalTrials.gov ID
- NCT05474768
- Acronym / sponsor ID
- 2021PI221
- Conditions
- Transgenderism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 26 Jul 2022 (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.
Hormonal treatment of gender dysphoria can have repercussions on metabolism, cardiovascular system and fertility and represents à potential oncological risk. According to the recommendations of the Endocrine society. Therefore, initial assessment and follow-up visits are necessary and must be carried out to avoid the apparition of potentially undesirable effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults with gender dysphoria and parent of adolescent/child presenting gender dysphoria, who are followed un the university hospital of Nancy
Key inclusion criteria (8 listed)
- being a parent of adolescent/child presenting Gender dysphoria
- adult subject (age > 18 years) presenting Gender dysphoria
- non-inclusion criteria
- Severe, uncontrolled psychiatric or somatic illness
- Chronic alcoholism
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Describe expectations and beliefs of transgener people about hormonal therapy
Time frame: 12 months
qualitative analysis of qualitative data from collective discussions (focus groups)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
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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.
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 Transgenderism, 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 8 inclusion and 0 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 26 Jul 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe expectations and beliefs of transgener people about hormonal therapy (time frame: 12 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 26 Jul 2022.