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Transgender In Transition (TRANSIT)

U

Universitätsklinikum Hamburg-Eppendorf

Status

Enrolling

Conditions

Gender Incongruence

Treatments

Diagnostic Test: Online surveys

Study type

Observational

Funder types

Other

Identifiers

NCT04028219
TRANSIT

Details and patient eligibility

About

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

Full 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.

Enrollment

750 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

750 participants in 1 patient group

Transgender patients
Description:
Gender dysphoric patients undergoing hormone treatment
Treatment:
Diagnostic Test: Online surveys

Trial contacts and locations

5

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Central trial contact

Johannes Fuß, MD; Johanna Schröder, PhD

Data sourced from clinicaltrials.gov

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