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Observational Study on Metabolism and Psychopathology in Transsexual Patients

NCT02185274 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-02-25

No results posted yet for this study

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.

Conditions

  • Transsexualism

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    collaborator OTHER

  • Institute for Sex Research and Forensic Psychiatry, Hamburg, Germany

    collaborator UNKNOWN

  • Hormon-und Stoffwechselzentrum München, Munich, Germany

    collaborator UNKNOWN

  • Max-Planck-Institute of Psychiatry

    lead OTHER

Principal Investigators

  • Matthias K Auer, MD · Max Planck Insitute of Psychiatry, Department of Neuroendocrinology

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2019-10-31
Completion
2019-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02185274 on ClinicalTrials.gov