Clinical trial NCT04028219: Transgender In Transition
Official title: Transgender In Transition: Metabolism, Behaviour and Psychopathology in Transsexual Patients Following Hormonal Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gender Incongruence
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with gender incongruence undergoing gender-affirming hormone treatment

Brief 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.

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

Primary outcomes:
measure: Mini International Neuropsychiatric Interview (MINI; Lecrubier et al., 1997)
timeFrame: 10 years
Secondary outcomes:
measure: Alcohol Use Disorders Identification Test-Consumption (Audit C; Wade et al., 2014)
timeFrame: 10 years
measure: Transgender Congruence Scale (TCS; Kozee et al., 2012)
timeFrame: 10 years
measure: Gender Congruence and Life Satisfaction Scale (GCLS; Jones et al., 2018)
timeFrame: 10 years
measure: Brief Symptom Inventory (BSI; Derogatis and Melisaratos, 1983)
timeFrame: 10 years
measure: Short Form 36 (SF-36; Jenkinson et al., 1993)
timeFrame: 10 years
measure: Patient Health Questionnaire-9 (PHQ-9; Löwe et al., 2004)
timeFrame: 10 years
measure: Beck Scale for Suicidal Ideation (BSSI; Beck et al., 1979)
timeFrame: 10 years
measure: Questionnaire for the Evaluation of Psychotherapy Processes / Fragebogen zur Evaluation von Psychotherapieverläufen (FEP-2; Lutz et al., 2009)
timeFrame: 10 years
measure: Barratt Impulsivity Scale / Barratt Impulsivitäts Skala (BIS-15; Meule et al., 2011)
timeFrame: 10 years
measure: Questionnaire for Empathy and Changing Perspectives / Fragebogen für Empathie und Perspektivenübernahme (EP; Paulus, 2009)
timeFrame: 10 years
measure: Autism-Spektrum-Quotient (AQ-10; Sappok et al., 2015)
timeFrame: 10 years
measure: Rosenberg Self-Esteem Scale (RSES; Robins et al., 2001)
timeFrame: 10 years
measure: Internalized Stigma of Mental Illness Inventory (ISMI-9; Hammer and Toland, 2017)
timeFrame: 10 years
measure: Multidimensional Sexuality Questionnaire (MSQ; Snell et al., 1993)
timeFrame: 10 years
measure: Sexual Desire Inventory (SDI; Spector et al., 1996)
timeFrame: 10 years
measure: Side Effects of Hormonetherapy Inventory / Fragebogen zu Nebenwirkungen der Hormontherapie
timeFrame: 10 years
measure: Borderline Symptom List (BSL-23; Bohus et al., 2009)
timeFrame: 10 years
measure: Core Autogynephilia Scale (CAS; Blanchard, 1989)
timeFrame: 10 years
measure: OPD Structure Questionnaire Short Version / OPD Strukturfragebogen Kurzversion (OPD-SFK; Ehrenthal et al., 2015)
timeFrame: 10 years
measure: Personality Inventory for DSM-5 Brief Form / Persönlichkeitsinventar für DSM-5 (PID-5-BF; Anderson et al., 2016)
timeFrame: 10 years
measure: Childhood Trauma Questionnaire (CTQ; Bernstein et al., 2003)
timeFrame: 10 years
measure: ENRICHD Social Support Inventory (ESSI; Mitchell et al., 2003)
timeFrame: 10 years
measure: Perseverative Thinking Questionnaire (PTQ; Ehring et al., 2011)
timeFrame: 10 years
measure: 2 Subscales of the Sensation Seeking Scale-V (SSS-V; Zuckerman, 2007): thrill- and adventure seeking & experience-seeking
timeFrame: 10 years
measure: Acrophobia Questionnaire (AQ; Cohen, 1977)
timeFrame: 10 years
measure: Trust and Reciprocity Questionnaire (TR; Cox, 2004)
timeFrame: 10 years
measure: Client Satisfaction Questionnaire (CTQ-8) / Fragebogen zur Patientenzufriedenheit (ZUF-8; Schmidt et al., 2002)
timeFrame: 10 years
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
state: Hessen
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Munich
country: Germany
facility: Medical Center of the Ludwig-Maximilians-University of Munich
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
Study officials:
affiliation: Institute for Sex Research, Sexual Medicine and Forensic Psychiatry
name: Johannes Fuß, MD
role: PRINCIPAL_INVESTIGATOR
References: