Transgender In Transition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Online surveys.
- Who it may be relevant to
- Registry conditions: Gender Incongruence. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Transgender In Transition: Metabolism, Behaviour and Psychopathology in Transsexual Patients Following Hormonal Treatment
Overview
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.
Interventions
- 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).
Primary outcome measures
- Mini International Neuropsychiatric Interview (MINI; Lecrubier et al., 1997) [Time frame: 10 years]
Secondary outcome measures (12)
- Alcohol Use Disorders Identification Test-Consumption (Audit C; Wade et al., 2014) [Time frame: 10 years]
- Transgender Congruence Scale (TCS; Kozee et al., 2012) [Time frame: 10 years]
- Gender Congruence and Life Satisfaction Scale (GCLS; Jones et al., 2018) [Time frame: 10 years]
- Brief Symptom Inventory (BSI; Derogatis and Melisaratos, 1983) [Time frame: 10 years]
- Short Form 36 (SF-36; Jenkinson et al., 1993) [Time frame: 10 years]
- Patient Health Questionnaire-9 (PHQ-9; Löwe et al., 2004) [Time frame: 10 years]
- Beck Scale for Suicidal Ideation (BSSI; Beck et al., 1979) [Time frame: 10 years]
- Questionnaire for the Evaluation of Psychotherapy Processes / Fragebogen zur Evaluation von Psychotherapieverläufen (FEP-2; Lutz et al., 2009) [Time frame: 10 years]
- Barratt Impulsivity Scale / Barratt Impulsivitäts Skala (BIS-15; Meule et al., 2011) [Time frame: 10 years]
- Questionnaire for Empathy and Changing Perspectives / Fragebogen für Empathie und Perspektivenübernahme (EP; Paulus, 2009) [Time frame: 10 years]
- Autism-Spektrum-Quotient (AQ-10; Sappok et al., 2015) [Time frame: 10 years]
- Rosenberg Self-Esteem Scale (RSES; Robins et al., 2001) [Time frame: 10 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 3 centers
- Universitätsklinikum Frankfurt — Frankfurt am Main
- University Medical Center Hamburg-Eppendorf — Hamburg
- Medical Center of the Ludwig-Maximilians-University of Munich — Munich
Switzerland · 2 centers
- Universitätsspital Basel — Basel
- UniversitätsSpital Zürich — Zurich
Identifiers
NCT: NCT04028219 · TRANSIT