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Gender IncongruenceTRANSITNCT04028219

Transgender In Transition

An observational study of Gender Incongruence, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Johannes Fuß, MD contact

+49 (0)40 7410-54232

jo.fuss@uke.de

Johanna Schröder, PhD contact

+49 (0)40 7410-57763

jo.schroeder@uke.de

5 sites in 2 countries

Germany3 sites, 3 recruiting
  • Universitätsklinikum Frankfurt

    Frankfurt am Main, Hesse, 60590

    Gesine Meyer, Dr., gesine.meyer@kgu.de

    Not yet recruiting
  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246

    Recruiting
  • Medical Center of the Ludwig-Maximilians-University of Munich

    Munich

    Matthias Auer, Dr., Matthias.Auer@med.uni-muenchen.de

    Not yet recruiting

Other trials in Germany

Switzerland2 sites, 2 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

    Not yet recruiting

Other trials in Switzerland

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.

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 groups in NCT04028219
Study groupRoleWhat they receive
Transgender patientsGender 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.

  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.

    Measured: 10 years

Secondary outcomes (27)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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.

  1. First posted22 Jul 2019
  2. Study start15 May 2019
  3. Primary completion15 May 2024 (estimated)
  4. Study completion15 May 2034 (estimated)

Resources

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
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

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.

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