Investigating the effects of hormone therapy in transgender individuals
Official title: Transgender In Transition: Metabolism, Behaviour and Psychopathology in Transsexual Patients Following Hormonal Treatment
Run by Universitätsklinikum Hamburg-Eppendorf · NCT04028219 · Data updated 2026-11-12
This study is trying to see how starting hormone therapy affects the mental and physical health of transgender individuals.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 750 (estimated) |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 5 sites (Frankfurt am Main, Hesse and 4 other locations) |
| Status | Recruiting |
| Started | May 15, 2019 |
| Main results expected | May 15, 2024 |
| Study ends | May 15, 2034 |
| Registry record updated | November 8, 2022 |
| Trial ID | NCT04028219 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with gender incongruence or gender dysphoria who have not yet started hormone therapy.
✕Probably not a fit
Patients who are currently pregnant or breastfeeding will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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University Medical Center Hamburg-Eppendorf
Hamburg, Germany Recruiting -
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany Not yet 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Cardiovascular effects of gender-affirming hormones in adults
This project tests whether masculinizing or feminizing gender-affirming hormone therapy changes heart and blood vessel health in transgender adults who have been on hormones for at least 12 months.
-
Observational study on adults seeking treatment for gender incongruence
This study is looking to see how well current medical and surgical treatments for gender incongruence work and how satisfied adults are with them, to help improve care for transgender and gender-diverse individuals.
-
Swiss prospective cohort of transgender and gender-diverse people
This project tests which social, medical, and biological factors are linked to health and well-being in transgender and gender-diverse people in Switzerland who are starting, undergoing, or have stopped gender-affirming care.
-
Evaluating health care for young people with gender incongruence
This study looks at how well the health care program for young people with gender incongruence in Denmark is working by checking their physical health and mental well-being.
-
Examining how tucking affects semen quality in trans women
This study is testing how tucking affects sperm quality in trans women who want to preserve their fertility before starting hormone therapy.
-
Gender-affirming hormone therapy for transgender individuals in China
This study is trying to understand how gender-affirming hormone therapy affects the physical and mental health of transgender individuals in China over a year.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.