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A European Network for the Investigation of Gender Incongruence

A European Network for the Investigation of Gender Incongruence

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01072825
Acronym
ENIGI
Enrollment
125
Registered
2010-02-22
Start date
2010-02-15
Completion date
2030-12-31
Last updated
2023-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical and Psychological Evaluation of Hormonal Therapy in Transsexual Persons

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.

Interventions

OTHERquestionnaires

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

BIOLOGICALblood 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

OTHERclinical evaluation

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

OTHERDermatology 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

OTHERBone evaluation

PQCT scanner, BMD assessment

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
physical and psychological effects of the hormonal treatment of transsexual personsannuallyevaluations will be done every 3 months the first year of therapy, every 6 months in the second year, and after sex reassignment surgery annually.

Countries

Belgium, Italy, Netherlands, Norway

Contacts

Primary ContactGuy T'Sjoen, MD
guy.tsjoen@ugent.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026