Actively Recruiting

Age: 0 - 18Years
All Genders
NCT06573177

Optimizing Individual Health Care for Young People With Gender Incongruence

Led by Rigshospitalet, Denmark · Updated on 2024-08-27

1300

Participants Needed

1

Research Sites

465 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Optimizing Individual Health Care for Young People With Gender Incongruence

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Accepted referral to the gender identity service.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Growth and Reproduction, Rigshospitalet

Copenhagen, Capital Region, Denmark, 2100

Actively Recruiting

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Research Team

K

Katharina M Main

CONTACT

A

Annamaria GE Giraldi

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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