A European Network for the Investigation of Gender Incongruence (ENIGI)
This study is currently recruiting participants.
Verified August 2012 by University Hospital, Ghent
Sponsor:
University Hospital, Ghent
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
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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 May 19, 2013