Transgender In Transition
TRANSIT
1 other identifier
observational
750
2 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2019
CompletedFirst Submitted
Initial submission to the registry
July 14, 2019
CompletedFirst Posted
Study publicly available on registry
July 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2034
ExpectedNovember 8, 2022
November 1, 2022
5 years
July 14, 2019
November 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Mini International Neuropsychiatric Interview (MINI; Lecrubier et al., 1997)
The Mini International Neuropsychiatric Interview (MINI; Lecrubier et al., 1997) is a short structured clinical interview which enables researchers to make diagnoses of psychiatric disorders according to DSM-IV or ICD-10 and was designed for epidemiological studies and multicenter clinical trials.
10 years
Secondary Outcomes (27)
Alcohol Use Disorders Identification Test-Consumption (Audit C; Wade et al., 2014)
10 years
Transgender Congruence Scale (TCS; Kozee et al., 2012)
10 years
Gender Congruence and Life Satisfaction Scale (GCLS; Jones et al., 2018)
10 years
Brief Symptom Inventory (BSI; Derogatis and Melisaratos, 1983)
10 years
Short Form 36 (SF-36; Jenkinson et al., 1993)
10 years
- +22 more secondary outcomes
Study Arms (1)
Transgender patients
Gender dysphoric patients undergoing hormone treatment
Interventions
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).
Eligibility Criteria
Individuals with gender incongruence undergoing gender-affirming hormone treatment
You may qualify if:
- 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
You may not qualify if:
- pregnancy or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Medical Center of the Ludwig-Maximilians-University of Munich
Munich, Germany
Universitätsspital Basel
Basel, 4031, Switzerland
UniversitätsSpital Zürich
Zurich, 8091, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johannes Fuß, MD
Institute for Sex Research, Sexual Medicine and Forensic Psychiatry
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2019
First Posted
July 22, 2019
Study Start
May 15, 2019
Primary Completion
May 15, 2024
Study Completion (Estimated)
May 15, 2034
Last Updated
November 8, 2022
Record last verified: 2022-11