Expectations and Beliefs of Transgender People Regarding... | NCT05474768

Studies
Expectations and Beliefs of Transgender People Regarding Hormonal Treatment

NCT05474768

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Jul 26, 2022Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Transgenderism

Interventions

no intervention

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2022Actual

Primary Completion Date

Nov 2022Estimated

Completion Date

Jan 2023Estimated

First Submitted Date

Jul 22, 2022

First Submission Date that Met QC Criteria

Jul 23, 2022

First Posted Date

Jul 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2022

Last Update Posted Date

Jul 26, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

EVA FEIGERLOVA, Principal investigator, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. Therefore, initial assessment and follow-up visits are necessary and must be carried out to avoid the apparition of potentially undesirable effects.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Describe expectations and beliefs of transgener people about hormonal therapy	qualitative analysis of qualitative data from collective discussions (focus groups)	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

adults with gender dysphoria and parent of adolescent/child presenting gender dysphoria, who are followed un the university hospital of Nancy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Nancy	Recruiting	Nancy			France

Condition Browse Module

MeSH Terms

ID	Term
D014189	Transsexualism

Ancestor Terms

ID	Term
D019529	Sexuality
D012725	Sexual Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided