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

This study is currently recruiting participants.
Verified June 2015 by University Hospital, Ghent
Sponsor:
ClinicalTrials.gov Identifier:
NCT01072825
First Posted: February 22, 2010
Last Update Posted: June 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Ghent
February 19, 2010
February 22, 2010
June 3, 2015
February 2010
January 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01072825 on ClinicalTrials.gov Archive Site
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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.
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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
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*   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 2016   (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:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Guy T'Sjoen, MD guy.tsjoen@ugent.be
Belgium,   Italy,   Netherlands,   Norway
Germany
 
NCT01072825
2009/622
No
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University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Guy T'Sjoen, MD University Hospital, Ghent
University Hospital, Ghent
June 2015