A European Network for the Investigation of Gender Incongruence

Recruiting

• Conditions: Physical and Psychological Evaluation of Hormonal Therapy in Transsexual Persons
• Interventions: Other: questionnaires; Biological: blood sampling; Other: clinical evaluation; Other: Dermatology evaluation; Other: Bone evaluation

• Registration Number: NCT01072825
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-15
• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
transgender people starting hormone treatment	blood sampling	-
transgender people starting hormone treatment	clinical evaluation	-
transgender people starting hormone treatment	Bone evaluation	-
transgender people starting hormone treatment	questionnaires	-
transgender people starting hormone treatment	Dermatology evaluation	-

Primary Outcome Measures

Name	Time	Method
physical and psychological effects of the hormonal treatment of transsexual persons	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.

Trial Locations

Locations (3)

Rikshospitalet University Hospital, University of Oslo; 🇳🇴 Oslo, Norway

Genderteam UZ Gent; 🇧🇪 Gent, Belgium

VU University Medical CenterAmsterdam; 🇳🇱 Amsterdam, Netherlands