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

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ClinicalTrials.gov Identifier: NCT01072825
Recruitment Status : Recruiting
First Posted : February 22, 2010
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
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.

Condition or disease Intervention/treatment
Physical and Psychological Evaluation of Hormonal Therapy in Transsexual Persons Other: questionnaires Biological: blood sampling Other: clinical evaluation Other: Dermatology evaluation Other: Bone evaluation

Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A European Network for the Investigation of Gender Incongruence
Study Start Date : February 2010
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2020

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072825


Contacts
Contact: Guy T'Sjoen, MD guy.tsjoen@ugent.be

Locations
Belgium
Genderteam UZ Gent Recruiting
Gent, Belgium
Contact: Guy T'Sjoen, MD       guy.tsjoen@ugent.be   
Principal Investigator: Guy T'Sjoen, MD         
Italy
Recruiting
Florence, Italy
Contact: Alessandra Fisher, MD         
Principal Investigator: Alessandra Fisher, MD         
Netherlands
VU University Medical CenterAmsterdam Recruiting
Amsterdam, Netherlands
Contact: Michael van Trotsenburg, MD       m.vantrotsenburg@vumc.nl   
Principal Investigator: Michael van Trotsenburg, MD         
Norway
Rikshospitalet University Hospital, University of Oslo Recruiting
Oslo, Norway
Contact: Thomas Schreiner       thomas.schreiner@rikshospitalet.no   
Principal Investigator: Thomas Schreiner, MD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Guy T'Sjoen, MD University Hospital, Ghent