Actively Recruiting
Klinefelter Syndrome and Testosterone Treatment in Puberty
Led by Lise Aksglæde · Updated on 2025-02-19
32
Participants Needed
1
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Klinefelter Syndrome and Testosterone Treatment in Puberty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of 47,XXY Klinefelter syndrome
- Age between 10 and 14 years at time of inclusion
- Luteinizing hormone level greater than +2 standard deviations by ultrasensitive assay
- Free testosterone level less than +2 standard deviations
- Signed consent from parents
You will not qualify if you...
- Previous or current testosterone treatment except for micropenis-related therapy
- Known hypersensitivity to testosterone or any component of the gel
- Known or suspected prostate cancer or breast carcinoma
- Participation in another clinical trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
L
Lise Aksglaede, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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