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
  Purpose

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 Intervention
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
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A European Network for the Investigation of Gender Incongruence

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 125
Study Start Date: February 2010
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01072825     History of Changes
Other Study ID Numbers: 2009/622
Study First Received: February 19, 2010
Last Updated: August 8, 2012
Health Authority: Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014