Klinefelter Syndrome and Testosterone Treatment in Puberty

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Klinefelter Syndrome

In brief

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.

Key facts

Study ID

NCT06294990

Run by

Lise Aksglæde

People needed

32

Starts

2024-08-15

Expected to finish

2029-12-31

Last updated by the study team

2025-02-19

Who can join

Age: 10 and older, up to 14. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Previous or ongoing T treatment except for TRT because of micropenis
• Contraindications to testosterone treatment known hypersensitivity to testosterone or to any other constituent of the gel known or suspected prostatic cancer or breast carcinoma
• Participation in any other clinical trial

Where it is running

• Copenhagen University Hospital, Rigshospitalet — Copenhagen, Denmark (enrolling)

Full record on ClinicalTrials.gov

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