NCT04028219

Transgender In Transition

Transgender In Transition: Metabolism, Behaviour and Psychopathology in Transsexual Patients Following Hormonal Treatment

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 750 (estimated)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective trial in gender dysphoric patients who undergo gender-affirming hormone therapy, aiming to investigate psychological, biological and behavioural consequences of hormonal therapy.

Detailed description

Gender-affirming hormone treatment impacts myriads of body functions, from which it has to be assumed that only a minority has already been elucidated so far. This project aims to investigate the consequences and health-related outcomes of various hormone therapies in the treatment of gender dysphoric patients. The main scientific interest lies in the research of the effects of sex hormones on psychological, metabolic and behavioural parameters. For this purpose, various investigations are aimed at, including a clinical-diagnostic interview (external rating) and psychometric measurements in self-rating, behavioral experiments (e.g. in a virtual reality Elevated Plus Maze and the computer-based Ultimatum Game) and genetic investigation of the body's own materials (blood samples, stool samples, hair samples and saliva samples). The results of this study should form the basis to better understand consequences of the long-term administration of sex hormones.

Conditions

• Gender Incongruence

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Online surveys	Psychometric measures within 14 online surveys, which is one at each assessment point (before and 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 months after hormonal therapy).

Timeline

• Start date: 2019-05-15
• Primary completion: 2024-05-15
• Completion: 2034-05-15
• First posted: 2019-07-22
• Last updated: 2022-11-08

Locations

5 sites across 2 countries: Germany, Switzerland