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Recruiting Observational

A European Network for the Investigation of Gender Incongruence

NCT01072825 · tracked via the Priya Life Science Norway tracker
Phase
Observational
Started
2010-02-15
Last updated
2026-09-21

Condition(s) studied

Physical and Psychological Evaluation of Hormonal Therapy in Transsexual Persons

Investigational drug(s) / intervention(s)

questionnairesblood sampling →clinical evaluationDermatology evaluationBone evaluation

questionnaires: a descriptive questionnaire, SF-36, , bone questionnaires, Baecke physical activity questionnaire, voice evaluation

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Transsexual persons older then 18 years, who are not yet treated with hormonal therapy. Exclusion Criteria: \-

Primary outcome measure(s)

  • 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 sites (4)

FacilityCityRegionStatus
Genderteam UZ Gent Ghent Belgium Recruiting
— Florence Italy Recruiting
VU University Medical CenterAmsterdam Amsterdam Netherlands Recruiting
Rikshospitalet University Hospital, University of Oslo Oslo Norway Recruiting

More University Hospital, Ghent trials in Norway

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01072825 on ClinicalTrials.gov ↗ ← All trials in Norway