Klinefelter Syndrome and Testosterone Treatment in Puberty
Recruiting
Phase 4
Interventional Study
Klinefelter Syndrome
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 10 – 14
- Sex
- Male
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 32 (estimated)
- Sponsor
- Lise Aksglæde · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Previous or ongoing T t…
Contacts