Transition in Transgender

Gender Dysphoria Clinical Trial

Official title:

Transition in Transgender: Physiological Changes in Brain and Behavior

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04736797
• Other study ID #: 19-176
• Status: Recruiting
• Start date: November 27, 2020
• Est. completion date: August 1, 2023

Study information

• Verified date: January 2021
• Source: RWTH Aachen University
• Contact: Ute Habel, Prof. Dr.
• Phone: + 492418080368
• Email: uhabel[@]ukaachen.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Methodological problems and missing studies in this area were mentioned several times with an emphasis on the need for longitudinal research.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. a diagnosed gender dysphoria (DSM 5) or gender incongruence (ICD-11)

2. the pursuit of hormone therapy

3. native German speakers

4. age: 18-55

5. written informed consent following oral and written information

6. persons who are legally competent and mentally able to follow the instructions of the staff

Exclusion Criteria:

1. drug abuse/addiction

2. first-degree relatives with psychotic disorders

3. pregnant or breastfeeding

4. traumatic brain injuries

5. neurological diseases

6. known internal, e.g. metabolic, endocrine or cardiac disorders

7. magnetic metal implants

8. hearing disorders, voice disorders and pronounced hoarseness

9. shift workers or irregular day-night rhythm

10. persons placed in an institution by order of the authorities or courts

11. persons who are in a dependent or employment relationship with the auditor

12. simultaneous participation in a clinical trial

13. hormone treatment already started

Related Conditions & MeSH terms

• Gender Dysphoria

Locations

Country	Name	City	State
Germany	Uniklinik RWTH Aachen	Aachen
Germany	Universitätsklinikum Tübingen	Tübingen

Sponsors (2)

Lead Sponsor	Collaborator
RWTH Aachen University	University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in anatomical MRI	measurment of anatomical differences between the groups and changes in the TG group throughout the gender-affirming hormone treatment	7 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset (corresponding time points are chosen for the healthy controls)
Primary	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	10 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
Primary	self-ratings regarding psychological well-being and psychiatric: Childhood Trauma Questionnaire	5-point likert scale	1 hour; assessed before gender affirming hormone therapy starts
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 1, 2, 4 and 6 months after onset
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 2, 4 and 6 months after onset
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
Primary	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	1 hour; assessed before gender affirming hormone therapy starts and 6 months after onset
Primary	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	5 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset