Gender DysphoriaNCT04736797
Transition in Transgender
An observational study of Gender Dysphoria, run by RWTH Aachen University at 2 sites in Germany.
Trial summary
The aim of this longitudinal, observational study is to investigate the effects of gender-affirming hormone treatment in FTM (female to male) and MTF (male to female) transgender (TG) people with regard to changes in brain structure and function as well as psychological and behavioral consequences. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender Dysphoria
- How many people
- 200 participants
- Where
- 2 sitesGermany
- Study dates
- 27 Nov 2020to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Transgender people seeking gender-affirming hormonal treatment who fullfill the inclusion criteria
Who may be able to join
- a diagnosed gender dysphoria (DSM 5) or gender incongruence (ICD-11)
- the pursuit of hormone therapy
- native German speakers
- age: 18-55
- written informed consent following oral and written information
- persons who are legally competent and mentally able to follow the instructions of the staff
Who cannot join
- drug abuse/addiction
- first-degree relatives with psychotic disorders
- pregnant or breastfeeding
- traumatic brain injuries
- neurological diseases
- known internal, e.g. metabolic, endocrine or cardiac disorders
Show all 13Show fewer
- magnetic metal implants
- hearing disorders, voice disorders and pronounced hoarseness
- shift workers or irregular day-night rhythm
- persons placed in an institution by order of the authorities or courts
- persons who are in a dependent or employment relationship with the auditor
- simultaneous participation in a clinical trial
- hormone treatment already started
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Uniklinik RWTH Aachen
Aachen, 52062
Ute Habel, Prof. Dr., +49 241 80 80368, uhabel@ukaachen.de
- Not yet recruiting
Universitätsklinikum Tübingen
Tübingen, 72076
Birgit Derntl, Prof. Dr., + 49 7071 29 85437, Birgit.Derntl@med.uni-tuebingen.de
About this study
Official title: Transition in Transgender: Physiological Changes in Brain and Behavior
The aim of this longitudinal, observational study is to investigate the effects of gender-affirming hormone treatment in FTM (female to male) and MTF (male to female) transgender (TG) people with regard to changes in brain structure and function as well as psychological and behavioral consequences. Methodological problems and missing studies in this area were mentioned several times with an emphasis on the need for longitudinal research.
Read the detailed description
Transgender (TG) is still a polarizing issue today. The lack of acceptance in society and often even in one's own family, the feeling of a lack of identity and connection with one's own body and the experienced discrimination all lead to a considerable degree of suffering in TG and elevated levels of psychiatric symptoms as well as a reduced quality of life. Many TG people seek hormonal treatment. Physical and psychological consequences of this treatment still need to be revealed.
To this aim, the investigators recruit TG people (MTF and FTM) who intend to seek gender-affirming hormonal treatment. Before treatment, various measures will be taken, including a semi-structured interview to assess psychiatric symptoms, self-ratings, behavioral experiments (to assess male/female face recognition and male/female voice perception), while functional MRI scans are taken to assess respective neural correlates. In addition, resting-state scans as well as anatomic images will be taken.
Six months after having started gender-affirming hormone treatment, participants will be reinvited to undergo the same study protocol.
In between testing sessions, patients will perform several online surveys regarding their psychological well-being.
- Conditions
- Gender Dysphoria
- Keywords
- Transgender, female to male, male to female, Hormone treatment, Gender reassignment
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Transgender people who seek hormone treatment | |
| Control participants | volunteers without gender dysphoria |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in anatomical MRI
measurment of anatomical differences between the groups and changes in the TG group throughout the gender-affirming hormone treatment
Measured: 7 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset (corresponding time points are chosen for the healthy controls)
changes in Resting-state MRI measurements
measurment of resting-state activation differences between the groups and changes in the TG group throughout the gender-affirming hormone treatment
Measured: 10 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in Functional MRI measurements
measurment of activation differences during a voice and a face gender-recognition task between the groups and changes in the TG group throughout the gender-affirming hormone treatment
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding quality of life throughout gender-affirming hormone treatment : WHOQoL-BREF
items regarding different aspects of daily life, 5-point likert scale, changes are measured for TG, CG are used as a control for potential natural changes over time
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding quality of life throughout gender-affirming hormone treatment: Gender Congruence and Life Satisfaction Scale
items regarding influence of gender congruence on different aspects of daily life, 5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Brief Symptom Inventory
occurence of different symptoms during the last week, 5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
self-ratings regarding psychological well-being and psychiatric: Childhood Trauma Questionnaire
5-point likert scale
Measured: 1 hour; assessed before gender affirming hormone therapy starts
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: ENRICHD Social Support Inventory
5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Positive and negative affect scale
5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Patient Health Questionnaire-9
items regarding depressive symptoms, 4-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset
changes in self-ratings regarding personality throughout gender-affirming hormone treatment: Personality Inventory for DSM-5 Brief Form
4-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Rosenberg Self-Esteem Scale
4-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Stait-Trait-Angst Inventar
4-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over timechanges are measured for TG, CG are used as a control for potential natural changes over time
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Stress- and Coping Inventar
7-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Strukturiertes Klinisches Interview für DSM 5
interview conducted by investigator with questions regarding symptoms of different psychiatric disorders; changes are measured for TG, CG are used as a control for potential natural changes over time
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding sexuality throughout gender-affirming hormone treatment: Multidimensional Sexuality Questionnaires
items regarding sexual relationships, 5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding gender congruence throughout gender-affirming hormone treatment:Transgender Congruence Scale
5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding sex roles throughout gender-affirming hormone treatment: Assessment of Gender-Related Attributes
items regarding typicale male and female personality traits, cognition and interests, 7-point likert scale
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 2, 4 and 6 months after onset
changes in self-ratings regarding sex roles throughout gender-affirming hormone treatment: Bem Sex Role Inventory
7-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in self-ratings regarding percpetion of and satisfaction with own body throughout gender-affirming hormone treatment : Fragebogen zur Beurteilung des eigenen Körpers
each item has to be rated as false or true, resulting in scores for the dimensions self-esteem, insecurities and external appearance; changes are measured for TG, CG are used as a control for potential natural changes over time
Measured: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
changes in Hormone/protein analyses throughout gender-affirming hormone treatment
(free) testosterone, estradiol, progesterone, BDNF; changes are measured for TG, CG are used as a control for potential natural changes over time
Measured: 5 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start27 Nov 2020
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Sponsor
- Investigators
- Ute Habel, Prof. Dr., Study director, Uniklinkum AachenBirgit Derntl, Prof. Dr., Study director, Uniklinikum Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736797
- Sponsor's protocol ID
- 19-176
- Status last verified
- Jan 2021
- First submitted
- 10 Mar 2020
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition in Transgender: Physiological Changes in Brain and Behavior
- ClinicalTrials.gov ID
- NCT04736797
- Acronym / sponsor ID
- 19-176
- Conditions
- Gender Dysphoria
- Keywords
- Transgender, female to male, male to female, Hormone treatment, Gender reassignment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 3 Feb 2021 (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.
The aim of this longitudinal, observational study is to investigate the effects of gender-affirming hormone treatment in FTM (female to male) and MTF (male to female) transgender (TG) people with regard to changes in brain structure and function as well as psychological and behavioral consequences. Methodological problems and missing studies in this area were mentioned several times with an emphasis on the need for longitudinal research.
Detailed description
Transgender (TG) is still a polarizing issue today. The lack of acceptance in society and often even in one's own family, the feeling of a lack of identity and connection with one's own body and the experienced discrimination all lead to a considerable degree of suffering in TG and elevated levels of psychiatric symptoms as well as a reduced quality of life. Many TG people seek hormonal treatment. Physical and psychological consequences of this treatment still need to be revealed.
To this aim, the investigators recruit TG people (MTF and FTM) who intend to seek gender-affirming hormonal treatment. Before treatment, various measures will be taken, including a semi-structured interview to assess psychiatric symptoms, self-ratings, behavioral experiments (to assess male/female face recognition and male/female voice perception), while functional MRI scans are taken to assess respective neural correlates. In addition, resting-state scans as well as anatomic images will be taken.
Six months after having started gender-affirming hormone treatment, participants will be reinvited to undergo the same study protocol.
In between testing sessions, patients will perform several online surveys regarding their psychological well-being.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | –Transgender people who seek hormone treatment |
| Control participants | – | –volunteers without gender dysphoria |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Transgender people seeking gender-affirming hormonal treatment who fullfill the inclusion criteria
Key inclusion criteria (6 listed)
- a diagnosed gender dysphoria (DSM 5) or gender incongruence (ICD-11)
- the pursuit of hormone therapy
- native German speakers
- age: 18-55
- written informed consent following oral and written information
Key exclusion criteria (13 listed)
- drug abuse/addiction
- first-degree relatives with psychotic disorders
- pregnant or breastfeeding
- traumatic brain injuries
- neurological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
changes in anatomical MRI
Time frame: 7 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset (corresponding time points are chosen for the healthy controls)
measurment of anatomical differences between the groups and changes in the TG group throughout the gender-affirming hormone treatment
changes in Resting-state MRI measurements
Time frame: 10 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset
measurment of resting-state activation differences between the groups and changes in the TG group throughout the gender-affirming hormone treatment
changes in Functional MRI measurements
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
measurment of activation differences during a voice and a face gender-recognition task between the groups and changes in the TG group throughout the gender-affirming hormone treatment
changes in self-ratings regarding quality of life throughout gender-affirming hormone treatment : WHOQoL-BREF
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
items regarding different aspects of daily life, 5-point likert scale, changes are measured for TG, CG are used as a control for potential natural changes over time
changes in self-ratings regarding quality of life throughout gender-affirming hormone treatment: Gender Congruence and Life Satisfaction Scale
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
items regarding influence of gender congruence on different aspects of daily life, 5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Brief Symptom Inventory
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
occurence of different symptoms during the last week, 5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
self-ratings regarding psychological well-being and psychiatric: Childhood Trauma Questionnaire
Time frame: 1 hour; assessed before gender affirming hormone therapy starts
5-point likert scale
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: ENRICHD Social Support Inventory
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset
5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Positive and negative affect scale
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Patient Health Questionnaire-9
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset
items regarding depressive symptoms, 4-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
changes in self-ratings regarding personality throughout gender-affirming hormone treatment: Personality Inventory for DSM-5 Brief Form
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
4-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Rosenberg Self-Esteem Scale
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
4-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Stait-Trait-Angst Inventar
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
4-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over timechanges are measured for TG, CG are used as a control for potential natural changes over time
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Stress- and Coping Inventar
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset
7-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
changes in self-ratings regarding psychological well-being and psychiatric Symptoms throughout gender-affirming hormone treatment: Strukturiertes Klinisches Interview für DSM 5
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
interview conducted by investigator with questions regarding symptoms of different psychiatric disorders; changes are measured for TG, CG are used as a control for potential natural changes over time
changes in self-ratings regarding sexuality throughout gender-affirming hormone treatment: Multidimensional Sexuality Questionnaires
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
items regarding sexual relationships, 5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
changes in self-ratings regarding gender congruence throughout gender-affirming hormone treatment:Transgender Congruence Scale
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
5-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
changes in self-ratings regarding sex roles throughout gender-affirming hormone treatment: Assessment of Gender-Related Attributes
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 2, 4 and 6 months after onset
items regarding typicale male and female personality traits, cognition and interests, 7-point likert scale
changes in self-ratings regarding sex roles throughout gender-affirming hormone treatment: Bem Sex Role Inventory
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
7-point likert scale; changes are measured for TG, CG are used as a control for potential natural changes over time
changes in self-ratings regarding percpetion of and satisfaction with own body throughout gender-affirming hormone treatment : Fragebogen zur Beurteilung des eigenen Körpers
Time frame: 1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
each item has to be rated as false or true, resulting in scores for the dimensions self-esteem, insecurities and external appearance; changes are measured for TG, CG are used as a control for potential natural changes over time
changes in Hormone/protein analyses throughout gender-affirming hormone treatment
Time frame: 5 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset
(free) testosterone, estradiol, progesterone, BDNF; changes are measured for TG, CG are used as a control for potential natural changes over time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ute Habel, Prof. Dr. study director
Uniklinkum Aachen
Birgit Derntl, Prof. Dr. study director
Uniklinikum Tübingen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Dysphoria, run by RWTH Aachen University at 2 sites in Germany.
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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ute Habel, Prof. Dr. (+ 492418080368, uhabel@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in anatomical MRI (time frame: 7 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset (corresponding time points are chosen for the healthy controls)). The study lists 21 primary outcomes in all. 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 12 Feb 2021.