A European Network for the Investigation of Gender Incongruence

NCT01072825 | Recruiting

• 1 other identifier: BC-01783 (EC 2009/622)
• Study Type: observational
• Target: 125
• Locations: 4 countries
• Sites: 4

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.

Conditions

Physical and Psychological Evaluation of Hormonal Therapy in Transsexual Persons

Outcome Measures

Primary Outcomes (1)

• 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.

  annually

Study Arms (1)

transgender people starting hormone treatment

Other: questionnaires; Biological: blood sampling; Other: clinical evaluation; Other: Dermatology evaluation; Other: Bone evaluation

Interventions

questionnaires OTHER

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

transgender people starting hormone treatment

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

transgender people starting hormone treatment

clinical evaluation OTHER

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

transgender people starting hormone treatment

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

transgender people starting hormone treatment

Bone evaluation OTHER

PQCT scanner, BMD assessment

transgender people starting hormone treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (4)

Genderteam UZ Gent

Ghent, Belgium

RECRUITING

Unknown Facility

Florence, Italy

RECRUITING

VU University Medical CenterAmsterdam

Amsterdam, Netherlands

RECRUITING

Rikshospitalet University Hospital, University of Oslo

Oslo, Norway

RECRUITING

Related Publications (3)

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

Related Links

• website of the University Hospital of Ghent

MeSH Terms

Interventions

Surveys and Questionnaires; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Guy T'Sjoen, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy T'Sjoen, MD

CONTACT

guy.tsjoen@ugent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 22, 2010
• Study Start: February 15, 2010
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 21, 2026

Record last verified: 2026-09

Locations

NL (1); BE (1); IT (1); NO (1)