Klinefelter Syndrome - the Effect of Testosterone Treatment in Puberty. a Randomized, Double-blind Placebo-controlled Intervention Study: 'The TiPY Study'
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The goal of this randomized clinical trial is to study the effect of testosterone replacement therapy during puberty in boys with Klinefelter syndrome (KS, 47,XXY). The main questions to answer are how treatment with testosterone will affect body fat mass, lipid and glucose metabolism, growth and body proportions, bone mineralization as well as effects on neurocognitive development and emotional and social difficulties. Participants will be randomized to two years treatment with testosterone or placebo.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 10
Maximum Age: 14
Healthy Volunteers: f
View:
• 47,XXY Klinefelter syndrome
• Age 10-14 years at inclusion
• Luteinizing Hormone \> +2 standard deviations (SD) by ultrasensitive luteinizing hormone assay
• Free Testosterone\<+2 standard deviations
• Signed consent from parents
Locations
Other Locations
Denmark
Copenhagen University Hospital, Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Lise Aksglaede, MD
lise.aksglaede@regionh.dk
+45 35455064
Time Frame
Start Date: 2024-08-15
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 32
Treatments
Active_comparator: Testosterone
Testosterone gel applied to the skin
Placebo_comparator: Placebo
Placebo gel applied to the skin
Related Therapeutic Areas
Sponsors
Leads: Lise Aksglæde