NCT05474768

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.

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 Feb 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

July 22, 2022

Last Update Submit

July 23, 2022

Conditions

Transgenderism

Outcome Measures

Primary Outcomes (1)

  • Describe expectations and beliefs of transgener people about hormonal therapy

    qualitative analysis of qualitative data from collective discussions (focus groups)

    12 months

Interventions

no interventionOTHER

no intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • being a parent of adolescent/child presenting Gender dysphoria
  • adult subject (age \> 18 years) presenting Gender dysphoria
  • Severe, uncontrolled psychiatric or somatic illness
  • Chronic alcoholism
  • Substance abuse
  • Refusal or linguistic, physical or psychological incapacity to participate in the study
  • Ongoing pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Nancy, France

RECRUITING

MeSH Terms

Conditions

Transsexualism

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 22, 2022

First Posted

July 26, 2022

Study Start

February 2, 2022

Primary Completion

November 1, 2022

Study Completion

January 1, 2023

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations

FR(1)