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Observational Study on Metabolism and Psychopathology in Transsexual Patients

M

Max-Planck-Institute of Psychiatry

Status

Completed

Conditions

Transsexualism

Study type

Observational

Funder types

Other

Identifiers

NCT02185274
MPIP-ENDO1

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

  • Patients with the diagnosis gender identity disorder (ICD-10: F64.0), who have given written informed consent following adequate oral and written information.

General Exclusion criteria

  • Patients below the age of 18
  • Legally incompetent patients
  • Prior intake of cross-sex hormones
  • Missing written informed consent
  • Intersexuality

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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