A European Network for the Investigation of Gender Incongruence

ConditionPhysical and Psychological Evaluation of Hormonal Therapy in Transsexual Persons

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity Hospital, Ghent

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

transsexual persons older than 18 years, who are not yet treated with hormonal therapy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

questionnaires
Other intervention
a descriptive questionnaire, SF-36, , bone questionnaires, Baecke physical activity questionnaire, voice evaluation
blood sampling
Biological/Vaccine
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
Other intervention
height, weight, blood pressure, chestcircumference, waist circumference, grip strength, measuring 2 ° and 4 ° finger, and Ferriman Gallwey score
Dermatology evaluation
Other intervention
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
Other intervention
PQCT scanner, BMD assessment

Treatment groups

125 Participants

are divided into 1 treatment group

Group A: transgender people starting hormone treatment5 interventions

Trial outcomes

Primary outcomes

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.

Time frame

annually

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

Source ClinicalTrials.gov

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