NCT04160364

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

August 13, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

November 8, 2019

Last Update Submit

August 11, 2020

Conditions

Keywords

childrenadolescentsparents

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Interventions

qualitative research via guided interview

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • Refusal to participate
  • Inability to be physically, psychologically or linguistically involved in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Eva Feigerlova, MD,PhD

    University Hospital of Nancy, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Feigerlova, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 13, 2019

Study Start

October 1, 2020

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

August 13, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Not planned

Locations