Recruiting

NCT Number: NCT01072825

A European Network for the Investigation of Gender Incongruence

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.

Recruiting

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Key information

Conditions

Physical and Psychological Evaluation of Hormonal Therapy in Transsexual Persons

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Genderteam UZ Gent, Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

questionnaires

Other

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

Blood sampling

Biological

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

height, weight, blood pressure, chestcircumference, waist circumference, grip strength, measuring 2 ° and 4 ° finger, and Ferriman Gallwey score

Dermatology evaluation

Other

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

PQCT scanner, BMD assessment

Primary outcomes

physical and psychological effects of the hormonal treatment of transsexual persons

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guy T'Sjoen, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: ENIGI

Important dates

Study start: 2010
Primary completion: 2030
Study completion: 2030
First posted: Feb 22, 2010
Registry last updated: Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.