A European Network for the Investigation of Gender Incongruence (ENIGI)

December 8, 2023 updated by: University Hospital, Ghent
The physical and psychological effects of the hormonal treatment of transsexual persons are not sufficiently described. 'Transparency' wants to answer this question in a prospective manner, in a multicenter study to describe these effects. The low prevalence of transsexualism was the stimulus to search for European partners for this Protocol. A common standardized hormonal protocol was designed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Gent, Belgium
        • Recruiting
        • Genderteam UZ Gent
        • Contact:
        • Principal Investigator:
          • Guy T'Sjoen, MD
  • Italy
      • Florence, Italy
        • Recruiting
        • Contact:
          • Alessandra Fisher, MD
        • Principal Investigator:
          • Alessandra Fisher, MD
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • VU University Medical CenterAmsterdam
        • Contact:
        • Principal Investigator:
          • Michael van Trotsenburg, MD
  • Norway
      • Oslo, Norway
        • Recruiting
        • Rikshospitalet University Hospital, University of Oslo
        • Contact:
        • Principal Investigator:
          • Thomas Schreiner, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

transsexual persons older than 18 years, who are not yet treated with hormonal therapy

Description

Inclusion Criteria:

  • Transsexual persons older then 18 years, who are not yet treated with hormonal therapy.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
transgender people starting hormone treatment
Other: questionnaires
a descriptive questionnaire, SF-36, , bone questionnaires, Baecke physical activity questionnaire, voice evaluation
Biological: blood sampling
LFT (AST, ALT), CRP, creatinine, glucose, Total Cholesterol, Triglycerides, HDL-CH, LDL-CH, 25OH vitamin D, PSA if> 45 years, Hematocrit, testosterone, sex hormone-binding globulin, free testosterone , oestradiol, prolactin, luteinizing hormone, TSH, androgeengevoeligheids test (CAG RL), oral glucose tolerance test
Other: clinical evaluation
height, weight, blood pressure, chestcircumference, waist circumference, grip strength, measuring 2 ° and 4 ° finger, and Ferriman Gallwey score
Other: Dermatology evaluation
Evaluation of the hair pattern, using the Leeds acne classification scale, acne scars through ECCA scale (échelle d'évaluation clinique des cicatrices d'acné), androgenetic alopecia, and sebummetrie
Other: Bone evaluation
PQCT scanner, BMD assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
physical and psychological effects of the hormonal treatment of transsexual persons
Time Frame: annually
evaluations will be done every 3 months the first year of therapy, every 6 months in the second year, and after sex reassignment surgery annually.
annually

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Guy T'Sjoen, MD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2010

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

February 19, 2010

First Submitted That Met QC Criteria

February 19, 2010

First Posted (Estimated)

February 22, 2010

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/622

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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