Investigating the effects of hormone therapy in transgender individuals
Transgender In Transition: Metabolism, Behaviour and Psychopathology in Transsexual Patients Following Hormonal Treatment
Universitätsklinikum Hamburg-Eppendorf · NCT04028219
This study is trying to see how starting hormone therapy affects the mental and physical health of transgender individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf (other) |
| Locations | 5 sites (Frankfurt am Main, Hesse and 4 other locations) |
| Trial ID | NCT04028219 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on individuals diagnosed with gender incongruence who are about to begin gender-affirming hormone therapy. It aims to explore the psychological, biological, and behavioral consequences of hormone treatment through various assessments, including clinical interviews, psychometric evaluations, and genetic analyses. Participants will provide blood, stool, hair, and saliva samples to better understand the long-term effects of sex hormones. The findings are expected to enhance knowledge about the health-related outcomes of hormone therapy in this population.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with gender incongruence or gender dysphoria who have not yet started hormone therapy.
Not a fit: Patients who are currently pregnant or breastfeeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of health outcomes for transgender individuals undergoing hormone therapy.
How similar studies have performed: Other studies have explored aspects of hormone therapy in transgender individuals, but this study's comprehensive approach to psychological and biological outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of gender incongruence (ICD-11) or gender dysphoria (DSM-5) * written informed consent following adequate oral and written Information * before gender-affirming hormonal treatment Exclusion Criteria: * pregnancy or breast-feeding
Where this trial is running
Frankfurt am Main, Hesse and 4 other locations
- Universitätsklinikum Frankfurt — Frankfurt am Main, Hesse, Germany (NOT_YET_RECRUITING)
- University Medical Center Hamburg-Eppendorf — Hamburg, Germany (RECRUITING)
- Medical Center of the Ludwig-Maximilians-University of Munich — Munich, Germany (NOT_YET_RECRUITING)
- Universitätsspital Basel — Basel, Switzerland (NOT_YET_RECRUITING)
- UniversitätsSpital Zürich — Zurich, Switzerland (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Johannes Fuß, MD — Institute for Sex Research, Sexual Medicine and Forensic Psychiatry
- Study coordinator: Johannes Fuß, MD
- Email: jo.fuss@uke.de
- Phone: +49 (0)40 7410-54232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gender Incongruence