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

This study is currently recruiting participants.
Verified August 2012 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01072825
First received: February 19, 2010
Last updated: August 8, 2012
Last verified: August 2012
History of Changes

February 19, 2010
August 8, 2012
February 2010
January 2015   (final data collection date for primary outcome measure)
physical and psychological effects of the hormonal treatment of transsexual persons [ Time Frame: annually ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01072825 on ClinicalTrials.gov Archive Site
Not Provided
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A European Network for the Investigation of Gender Incongruence
A European Network for the Investigation of Gender Incongruence

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

transsexual persons older than 18 years, who are not yet treated with hormonal therapy
Physical and Psychological Evaluation of Hormonal Therapy in Transsexual Persons
  • 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
transgender people starting hormone treatment
Interventions:
  • Other: questionnaires
  • Biological: blood sampling
  • Other: clinical evaluation
  • Other: Dermatology evaluation
  • Other: Bone evaluation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
125
January 2020
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

-
Both
18 Years and older
No
Contact: Guy T'Sjoen, MD guy.tsjoen@ugent.be
Belgium,   Italy,   Netherlands,   Norway
 
NCT01072825
2009/622
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Guy T'Sjoen, MD University Hospital, Ghent
University Hospital, Ghent
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP