Klinefelter syndrome – the effect of Testosterone treatment In PubertYA randomized, double-blind placebo-controlled intervention study ‘The TiPY study’
Phase 1
- Conditions
- 47,XXY (Klinefelter syndrome)Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- CTIS2023-505854-16-00
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 32
Inclusion Criteria
*Boys with Klinefelter syndrome (with a 47,XXY karyotype verified by conventional chromosome analysis or ArrayCGH). *Age 10-14 years at inclusion *LH > +2 standard deviations (SD) by ultrasensitive LH assay *Free T<+2SD *Signed consent from parents
Exclusion Criteria
*Previous or ongoing T treatment except for TRT because of micropenis during minipuberty *Contraindications to testosterone treatment *Participation in any other clinical trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary study objective is to evaluate the effect of two years testosterone replacement therapy (TRT) during puberty in boys with Klinefelter syndrome on <br>•changes in body composition;Secondary Objective: The secondary study objectives are to evaluate effects of two years testosterone replacement therapy (TRT) during puberty in boys with Klinefelter syndrome on •pubertal development and virilization, Effect on growth and body proportions, Effect on lipid and glucose metabolism and systemic inflammation, Effect on neurocognitive development, adaptive behavioral functioning, psychopathology and quality of life, Effect on bone mineralization, Effect on muscle strength, Effect on QTc (ECG), Effect on fertility;Primary end point(s): Change in body composition as evaluated by whole body dual energy x-ray absorptiometry (DEXA) scan and measurement of body fat percentage, ratio between android and gynoid fat percentage and muscle mass.
- Secondary Outcome Measures
Name Time Method