Optimizing Individual Health Care for Young People With Gender Incongruence

NCT ID: NCT06573177

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2030-12-31

Brief Summary

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This observational study focuses on evaluating the effect of the current health care program for Danish children and adolescents with gender incongruence, which was established in January 2016. Somatic outcome parameters include growth, bone health, body composition, metabolic parameters, hormone levels and concurrent diseases. Psychosocial parameters include the trajectory of gender incongruence development, mental health, i.e. autism spectrum disorders, behavioural problems, self-harm, suicidal ideation and psychiatric diagnoses, and social context, i.e. family demographics, education, minority stress.

This study aims to:

1. Characterise the psychosocial profile of all children and adolescents referred for treatment, as well as the history of gender identity development and treatment trajectories.
2. Systematically evaluate biological parameters before and during hormonal treatment with gonadotropin-releasing hormone (GnRH) analogues and cross-sex hormones, and to establish a biobank for those in hormone treatment.

The investigators hypothesise that intervention with counselling and hormonal treatment is safe and has a positive impact on psychosocial well-being of transgender youngsters. The overall aim is to provide data for improving future family counselling, clinical care, patient satisfaction, patient safety and ultimately quality-of-life.

Detailed Description

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Conditions

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Gender Incongruence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Referral to the gender identity service.

Referral to the national gender identity service consisting of the Sexological Clinic, Child and Adolescent Mental Health Center, and Department of Growth and Reproduction in the Capital Region of Denmark.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Accepted referral to the gender identity service.

Exclusion Criteria

* None.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Katharina Maria Main

Prof. MD, Ph.d.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katharina M Main

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Department of Growth and Reproduction, Rigshospitalet

Copenhagen, Capital Region, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Katharina M Main

Role: CONTACT

+4535455085

Annamaria GE Giraldi

Role: CONTACT

Facility Contacts

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Katharina M Main

Role: primary

+4535455085

Other Identifiers

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H-18050607

Identifier Type: -

Identifier Source: org_study_id

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