Gender IncongruenceTRANSITNCT04028219
Transgender In Transition
An observational study of Gender Incongruence, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in 2 countries.
Trial summary
Prospective trial in gender dysphoric patients who undergo gender-affirming hormone therapy, aiming to investigate psychological, biological and behavioural consequences of hormonal therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gender Incongruence
- What is being tested?
- Online surveys
- How many people
- 750 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 15 May 2019to 15 May 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with gender incongruence undergoing gender-affirming hormone treatment
Who may be able to join
- 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
Who cannot join
- pregnancy or breast-feeding
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Germany3 sites, 3 recruiting
- Not yet recruiting
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60590
Gesine Meyer, Dr., gesine.meyer@kgu.de
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
- Not yet recruiting
Medical Center of the Ludwig-Maximilians-University of Munich
Munich
Matthias Auer, Dr., Matthias.Auer@med.uni-muenchen.de
Switzerland2 sites, 2 recruiting
- Not yet recruiting
Universitätsspital Basel
Basel, 4031
Garcia Nunez, Dr., David.Garcia@usb.ch
- Not yet recruiting
UniversitätsSpital Zürich
Zurich, 8091
Lena Jellestadt, Dr., Lena.Jellestad@usz.ch
About this study
Official title: Transgender In Transition: Metabolism, Behaviour and Psychopathology in Transsexual Patients Following Hormonal Treatment
Prospective trial in gender dysphoric patients who undergo gender-affirming hormone therapy, aiming to investigate psychological, biological and behavioural consequences of hormonal therapy.
Read the 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
- Being tested
- Online surveys
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online surveysDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| Transgender patients | Gender dysphoric patients undergoing hormone treatment Receives: Diagnostic Test: Online surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (27)
Alcohol Use Disorders Identification Test-Consumption (Audit C; Wade et al., 2014)
The Alcohol Use Disorders Identification Test-Consumption (Audit C; Wade et al., 2014) measures the consumption of alcohol in the past 12 months via a self-rating of 3 items. For the planned study, further equivalent versions for the consumption of nicotine and cannabis were adapted with 9 items covering consumption behaviour.
Measured: 10 years
Transgender Congruence Scale (TCS; Kozee et al., 2012)
The Transgender Congruence Scale (TCS; Kozee et al., 2012) measures gender congruence via self-rating through twelve items and two subscales (congruence with appearance \& acceptance of gender identity) within the past two weeks.
Measured: 10 years
Gender Congruence and Life Satisfaction Scale (GCLS; Jones et al., 2018)
The Gender Congruence and Life Satisfaction Scale (GCLS; Jones et al., 2018) measures gender congruence and life satisfaction via self-rating through 38 items and seven subscales (genitals, breast, other secondary sexual characteristics, recognition of gender role, physical and emotional intimacy, physiological function and life satisfaction) with a time frame of six months.
Measured: 10 years
Brief Symptom Inventory (BSI; Derogatis and Melisaratos, 1983)
The Brief Symptom Inventory (BSI; Derogatis and Melisaratos, 1983) measures psychiatric symptoms via self-rating with a total of 53 items in the areas of somatisation, compulsivity, insecurity in social contact, depression, anxiety, aggression, phobic fear, paranoid thinking and psychoticism. The inventory refers to a description of the symptoms within the past week.
Measured: 10 years
Short Form 36 (SF-36; Jenkinson et al., 1993)
The Short Form 36 (SF-36; Jenkinson et al., 1993) measures the health-related quality of life in the past month via self-rating with a total of 36 items, whereby it refers to the following areas: Vitality, physical functioning, physical pain, general health perception, physical role function, emotional role function, social functioning and psychological well-being.
Measured: 10 years
Patient Health Questionnaire-9 (PHQ-9; Löwe et al., 2004)
The Patient Health Questionnaire-9 (PHQ-9; Löwe et al., 2004) measures the severity of depression symptoms via self-rating. The PHQ-9 is one of the most widely used depression questionnaires worldwide and enables the estimation of realistic basic rates of diagnosis of major depression.
Measured: 10 years
Beck Scale for Suicidal Ideation (BSSI; Beck et al., 1979)
The Beck Scale for Suicidal Ideation (BSSI; Beck et al., 1979) measures the degree of suicidal tendencies within the past week by self-rating with 21 items.
Measured: 10 years
Questionnaire for the Evaluation of Psychotherapy Processes / Fragebogen zur Evaluation von Psychotherapieverläufen (FEP-2; Lutz et al., 2009)
The questionnaire for the evaluation of psychotherapy processes (FEP-2; Lutz et al., 2009) is a self-rating instrument comprising 40 items and is used for quality assurance in psychiatric/psychotherapeutic treatments. This questionnaire covers the areas of well-being, symptom burden, interpersonal problems and incongruity within the past week.
Measured: 10 years
Barratt Impulsivity Scale / Barratt Impulsivitäts Skala (BIS-15; Meule et al., 2011)
The short form of the Barratt Impulsivity Scale (BIS-15; Meule et al., 2011) measures various forms of impulsivity (motor, planning, attention) via self-rating based on 15 items.
Measured: 10 years
Questionnaire for Empathy and Changing Perspectives / Fragebogen für Empathie und Perspektivenübernahme (EP; Paulus, 2009)
The Questionnaire for Empathy and Changing Perspectives (EP; Paulus, 2009) uses self-rating with a total of 18 items to determine the ability to empathize and to change perspectives in the areas of empathy, social sensitivity and prosocial behaviour.
Measured: 10 years
Autism-Spektrum-Quotient (AQ-10; Sappok et al., 2015)
The short version of the autism spectrum quotient (AQ-10; Sappok et al., 2015) is a screening instrument for recording autistic traits via self-rating that comprises 10 items.
Measured: 10 years
Rosenberg Self-Esteem Scale (RSES; Robins et al., 2001)
The Rosenberg Self-Esteem Scale (RSES; Robins et al., 2001) measures self-esteem via self-rating with 10 items.
Measured: 10 years
Internalized Stigma of Mental Illness Inventory (ISMI-9; Hammer and Toland, 2017)
The Internalized Stigma of Mental Illness Inventory (ISMI-9; Hammer and Toland, 2017) measures the tendency towards self-stigmatization in psychiatric populations via self-rating with 9 items.
Measured: 10 years
Multidimensional Sexuality Questionnaire (MSQ; Snell et al., 1993)
The Multidimensional Sexuality Questionnaire (MSQ; Snell et al., 1993) is a self-rating instrument for recording various psychological dimensions of sexuality. For economic reasons, a selection of three subscales (sexual anxiety, depression and satisfaction) will be specified in the current project. This selection comprises a total of 14 items.
Measured: 10 years
Sexual Desire Inventory (SDI; Spector et al., 1996)
The Sexual Desire Inventory (SDI; Spector et al., 1996) measures sexual desire in the past month via self-rating with 13 items. There are two different subscales for desire with and desire without social interaction (solitary and dyadic sexual desire).
Measured: 10 years
Side Effects of Hormonetherapy Inventory / Fragebogen zu Nebenwirkungen der Hormontherapie
This specially for the current study developed questionnaire on side effects of hormone therapy uses self-rating to record various psychological and physiological symptoms that were observed during transition treatments with gender, sexual desire and sexual desire in 23 items.
Measured: 10 years
Borderline Symptom List (BSL-23; Bohus et al., 2009)
The Borderline Symptom List (BSL-23; Bohus et al., 2009) measures symptoms that typically occur in the context of borderline personality disorder via self-rating with 34 items. The time frame refers to the previous week.
Measured: 10 years
Core Autogynephilia Scale (CAS; Blanchard, 1989)
The Core Autogynephilia Scale (CAS; Blanchard, 1989) meassures autogynephile tendencies via self-rating with 9 items. For the planned study, an equivalent version (Core Autoandrophilia Scale) was adapted to be able to measure autoandrophilic tendencies equally.
Measured: 10 years
OPD Structure Questionnaire Short Version / OPD Strukturfragebogen Kurzversion (OPD-SFK; Ehrenthal et al., 2015)
The OPD Structure Questionnaire Short Version (OPD-SFK; Ehrenthal et al., 2015) uses self-rating with a total of 12 items in order to measure structural abilities in the dimensions of self-perception, contact design and relationship model.
Measured: 10 years
Personality Inventory for DSM-5 Brief Form / Persönlichkeitsinventar für DSM-5 (PID-5-BF; Anderson et al., 2016)
The personality inventory for DSM-5 Brief Form (PID-5 BF; Anderson et al., 2016) measures pathological personality traits via self-rating with a total of 25 items, which are described by the following subscales: Negative affectivity, closure, antagonism, disinhibition and psychoticism.
Measured: 10 years
Childhood Trauma Questionnaire (CTQ; Bernstein et al., 2003)
The Childhood Trauma Questionnaire (CTQ; Bernstein et al., 2003) is a self-evaluation tool suitable for retrospectively recording abuse and neglect in childhood and adolescence. The CTQ measures more than traumatic events in the narrower sense (according to DSM-IV and ICD-10). The CTQ scales include abuse (with three subscales: emotional, physical, sexual) and neglect (with two subscales: emotional and physical). The subscales consist of five items each. In addition, a further scale (three items) is provided to measure tendencies to trivialize or deny child abuse experiences. The items are rated on a 5-level scale (1-5 from 'not at all' to 'very often').
Measured: 10 years
ENRICHD Social Support Inventory (ESSI; Mitchell et al., 2003)
The ENRICHD Social Support Inventory (ESSI; Mitchell et al., 2003) measures the perception of social support via self-rating with 5 items.
Measured: 10 years
Perseverative Thinking Questionnaire (PTQ; Ehring et al., 2011)
The Perseverative Thinking Questionnaire (PTQ; Ehring et al., 2011) measures the extent of brooding thoughts via self-rating with 15 items.
Measured: 10 years
2 Subscales of the Sensation Seeking Scale-V (SSS-V; Zuckerman, 2007): thrill- and adventure seeking & experience-seeking
The Sensation Seeking Scale-V (SSS-V; Zuckerman, 2007) measures individual differences in sensation seeking via self-rating on the basis of various dimensions, which are: Thrill and Adventure Seeking (TAS), Disinhibition (Dis), Experience Seeking (ES), and Boredom Susceptibility (BS). Each subscale contains 10 items. For economic reasons, only two subscales (TAS \& ES) are used in the current project.
Measured: 10 years
Acrophobia Questionnaire (AQ; Cohen, 1977)
The Acrophobia Questionnaire (AQ; Cohen, 1977) is a self-rating questionnaire measuring acrophobia (fear of heights). The AQ describes 20 situations (e.g. standing next to an open window in an upper floor), which are often regarded by acrophobic patients as anxiety provoking and asks the extent of the anxiety (0-6) and avoidance behaviour (0-3). A total of 0-180 points can be achieved.
Measured: 10 years
Trust and Reciprocity Questionnaire (TR; Cox, 2004)
The Trust and Reciprocity Questionnaire (TR; Cox, 2004) measures trust and reciprocity via self-rating with 9 items.
Measured: 10 years
Client Satisfaction Questionnaire (CTQ-8) / Fragebogen zur Patientenzufriedenheit (ZUF-8; Schmidt et al., 2002)
The Client Satisfaction Questionnaire CSQ-8 (ZUF-8; Schmidt et al., 2002) is a validated self-rating questionnaire on satisfaction with treatment in psychiatric clinics. This questionnaire has been adapted for the current study so that patient satisfaction with hormone treatment is measured.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start15 May 2019
- Primary completion15 May 2024 (estimated)
- Study completion15 May 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender IncongruenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Fuß, MD, Principal investigator, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028219
- Sponsor's protocol ID
- TRANSIT
- Acronym
- TRANSIT
- Status last verified
- Nov 2022
- First submitted
- 14 Jul 2019
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transgender In Transition: Metabolism, Behaviour and Psychopathology in Transsexual Patients Following Hormonal Treatment
- ClinicalTrials.gov ID
- NCT04028219
- Acronym / sponsor ID
- TRANSIT / TRANSIT
- Conditions
- Gender Incongruence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 May 2034 (estimated)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transgender patients | – | Diagnostic Test: Online surveysGender dysphoric patients undergoing hormone treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with gender incongruence undergoing gender-affirming hormone treatment
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- pregnancy or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online surveysPsychometric 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). | Diagnostic test | Transgender patients |
Primary outcome
Mini International Neuropsychiatric Interview (MINI; Lecrubier et al., 1997)
Time frame: 10 years
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.
27 secondary outcomes
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
Internalized Stigma of Mental Illness Inventory (ISMI-9; Hammer and Toland, 2017)
Time frame: 10 years
Multidimensional Sexuality Questionnaire (MSQ; Snell et al., 1993)
Time frame: 10 years
Sexual Desire Inventory (SDI; Spector et al., 1996)
Time frame: 10 years
Side Effects of Hormonetherapy Inventory / Fragebogen zu Nebenwirkungen der Hormontherapie
Time frame: 10 years
Borderline Symptom List (BSL-23; Bohus et al., 2009)
Time frame: 10 years
Core Autogynephilia Scale (CAS; Blanchard, 1989)
Time frame: 10 years
OPD Structure Questionnaire Short Version / OPD Strukturfragebogen Kurzversion (OPD-SFK; Ehrenthal et al., 2015)
Time frame: 10 years
Personality Inventory for DSM-5 Brief Form / Persönlichkeitsinventar für DSM-5 (PID-5-BF; Anderson et al., 2016)
Time frame: 10 years
Childhood Trauma Questionnaire (CTQ; Bernstein et al., 2003)
Time frame: 10 years
ENRICHD Social Support Inventory (ESSI; Mitchell et al., 2003)
Time frame: 10 years
Perseverative Thinking Questionnaire (PTQ; Ehring et al., 2011)
Time frame: 10 years
2 Subscales of the Sensation Seeking Scale-V (SSS-V; Zuckerman, 2007): thrill- and adventure seeking & experience-seeking
Time frame: 10 years
Acrophobia Questionnaire (AQ; Cohen, 1977)
Time frame: 10 years
Trust and Reciprocity Questionnaire (TR; Cox, 2004)
Time frame: 10 years
Client Satisfaction Questionnaire (CTQ-8) / Fragebogen zur Patientenzufriedenheit (ZUF-8; Schmidt et al., 2002)
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Gender Incongruence
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China Gender-affirming Hormone Therapy Study
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GLOW: Gender-Affirming Care and Mental Health: A Longitudinal Study On Quality of Life, Work Life, and Healthcare Outcomes
Gender Dysphoria, Adult
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Puberty, Testosterone, and Brain Development
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johannes Fuß, MD principal investigator
Institute for Sex Research, Sexual Medicine and Forensic Psychiatry
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Incongruence, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes Fuß, MD (+49 (0)40 7410-54232, jo.fuss@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini International Neuropsychiatric Interview (MINI; Lecrubier et al., 1997) (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.