NCT04736797

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

November 27, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

February 12, 2021

Status Verified

January 1, 2021

Enrollment Period

2.7 years

First QC Date

March 10, 2020

Last Update Submit

February 9, 2021

Conditions

Gender Dysphoria

Keywords

Transgenderfemale to malemale to femaleHormone treatmentGender reassignment

Outcome Measures

Primary Outcomes (21)

  • 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)

  • 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

  • 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

  • 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

  • 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

  • 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

  • self-ratings regarding psychological well-being and psychiatric: Childhood Trauma Questionnaire

    5-point likert scale

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    5 minutes; assessed before gender affirming hormone therapy starts and 6 months after onset

Study Arms (2)

Patient

Transgender people who seek hormone treatment

Control participants

volunteers without gender dysphoria

Eligibility Criteria

Age18 Years - 55 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Transgender people seeking gender-affirming hormonal treatment who fullfill the inclusion criteria

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Uniklinik RWTH Aachen

Aachen, 52062, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Ute Habel, Prof. Dr.

    Uniklinkum Aachen

    STUDY DIRECTOR

  • Birgit Derntl, Prof. Dr.

    Uniklinikum Tübingen

    STUDY DIRECTOR

Central Study Contacts

Ute Habel, Prof. Dr.

CONTACT

+ 492418080368uhabel@ukaachen.de

Birgit Derntl, Prof. Dr.

CONTACT

+ 49 7071 29 85437Birgit.Derntl@med.uni-tuebingen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2020

First Posted

February 3, 2021

Study Start

November 27, 2020

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

February 12, 2021

Record last verified: 2021-01

Locations

DE(2)