Recruiting NCT01072825
A European Network for the Investigation of Gender Incongruence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: questionnaires, blood sampling, clinical evaluation, Dermatology evaluation.
- Who it may be relevant to
- Registry conditions: Physical and Psychological Evaluation of Hormonal Therapy in Transsexual Persons. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Italy, Netherlands, Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- physical and psychological effects of the hormonal treatment of transsexual persons [Time frame: annually]
Eligibility criteria
Inclusion criteria
- Transsexual persons older then 18 years, who are not yet treated with hormonal therapy.
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Genderteam UZ Gent — Ghent
Italy · 1 center
- Center not named — Florence
Netherlands · 1 center
- VU University Medical CenterAmsterdam — Amsterdam
Norway · 1 center
- Rikshospitalet University Hospital, University of Oslo — Oslo
Publications
- Shadid S, Abosi-Appeadu K, De Maertelaere AS, Defreyne J, Veldeman L, Holst JJ, Lapauw B, Vilsboll T, T'Sjoen G. Effects of Gender-Affirming Hormone Therapy on Insulin Sensitivity and Incretin Responses in Transgender People. Diabetes Care. 2020 Feb;43(2):411-417. doi: 10.2337/dc19-1061. Epub 2019 Nov 18. PMID 31740479
- Auer MK, Ebert T, Pietzner M, Defreyne J, Fuss J, Stalla GK, T'Sjoen G. Effects of Sex Hormone Treatment on the Metabolic Syndrome in Transgender Individuals: Focus on Metabolic Cytokines. J Clin Endocrinol Metab. 2018 Feb 1;103(2):790-802. doi: 10.1210/jc.2017-01559. PMID 29216353
- Bultynck C, Pas C, Defreyne J, Cosyns M, den Heijer M, T'Sjoen G. Self-perception of voice in transgender persons during cross-sex hormone therapy. Laryngoscope. 2017 Dec;127(12):2796-2804. doi: 10.1002/lary.26716. Epub 2017 Jul 21. PMID 28730692
Identifiers
NCT: NCT01072825 · 2009/622