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Clinical Trials/NCT02185274
NCT02185274
Completed
Not Applicable

Observational Study on the Short- and Long-term Effects of Cross-sex-hormone Treatment on Metabolism and Psychopathology in Transsexuals Patients.

Max-Planck-Institute of Psychiatry3 sites in 1 country100 target enrollmentOctober 2013
ConditionsTranssexualism

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transsexualism
Sponsor
Max-Planck-Institute of Psychiatry
Enrollment
100
Locations
3
Primary Endpoint
Incidence of depressive and anxious symptoms following initiation of cross-sex hormone treatment
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Gender identity disorders (also known as transsexualism) is defined as a condition in which a person with apparently normal somatic sexual differentiation is convinced that he or she is actually a member of the other sex. Most patients therefore undergo so called cross-sex hormone treatment. Treatment protocols follow international consensus statements but vary considerably between different centres and countries since no prospective and controlled trials are available on this subject and recommendations are mainly based on retrospective data analysis and experience of the individual centres. Applying high doses of testosterone to biological females and vice versa high doses of estradiol to biological males definitely impacts myriads of body functions, from which it has to be assumed that only a minority has already been elucidated so far. Especially in male-to-female-transsexuals there seems to be an increased risk for the development of mood disorders and cardiometabolic comorbidities. In this multi-center observational study we want to investigate, if there is any difference with regard to these outcomes, according to the varying standards of cross-sex hormone treatment between the different centers. Different outcome measures described below will be assessed each time during routine visits at the different centers.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
November 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Max-Planck-Institute of Psychiatry
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Incidence of depressive and anxious symptoms following initiation of cross-sex hormone treatment

Time Frame: Up to 5 years

Incidence of depressive and anxious symptoms by means of clinical interview and questionnaires in the the study period defined by different cut-off points in the point scales of the corresponding questionnaire (Beck Depression Inventory II = BDII and Symptomcheckliste bei psychischen Störungen = SCL90 for depression and State and Trait Anxiety Inventory = STAI-X1, X2 for anxiety). A comparison will then be done between the different treatment modes.

Differences in the effects of the different treatment types on cardiometabolic parameters

Time Frame: Up to 5 years

Differences in the effects of the different treatment types (differing in dose, application route and type of antiandrogen used) on cardiometabolic risk-parameters such as BMI, body-composition, fasting Insulin, fasting glucose, triglycerides, cholesterol, intima media thickness.

Secondary Outcomes

  • Effects of cross-sex hormone treatment on cortisol secretion by hair cortisol measurements(Up to 5 years)
  • Effects of cross-sex hormone treatment on stress-response by means of Dex/CRH-testing(Up to 5 years)
  • Genetic predictors for treatment response(Up to 5 years)
  • Effects of cross-sex hormone treatment on the metabolome(Up to 5 years)
  • Effects of cross-sex hormone treatment on peripheral neurotrophins(Up to 5 years)
  • Association of hair cortisol and cortisol response during dex/crh-testing with psychopathology-scores assessed by clinical interview and questionnaires(Up to 5 years)
  • Predictive value of hair cortisol and cortisol response in dex/crh-testing treatment for depression and anxiety(Up to 5 years)

Study Sites (3)

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