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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014