A European Network for the Investigation of Gender Incongruence

Physical and Psychological Evaluation of Hormonal Therapy in Transsexual Persons Clinical Trial

— ENIGI  

Official title:

A European Network for the Investigation of Gender Incongruence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01072825
• Other study ID #: 2009/622
• Status: Recruiting
• Start date: February 15, 2010
• Est. completion date: December 31, 2030

Study information

• Verified date: December 2023
• Source: University Hospital, Ghent
• Contact: Guy T'Sjoen, MD
• Email: guy.tsjoen[@]ugent.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Gender Dysphoria
• Physical and Psychological Evaluation of Hormonal Therapy in Transsexual Persons

Intervention

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
• 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
• Bone evaluation
PQCT scanner, BMD assessment

Locations

Country	Name	City	State
Belgium	Genderteam UZ Gent	Gent
Netherlands	VU University Medical CenterAmsterdam	Amsterdam
Norway	Rikshospitalet University Hospital, University of Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical and psychological effects of the hormonal treatment of transsexual persons	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.	annually