Klinefelter Syndrome and Testosterone Treatment in Puberty

Launched by LISE AKSGLÆDE · Mar 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how testosterone replacement therapy affects boys with Klinefelter syndrome (a genetic condition where boys have an extra X chromosome) during puberty. The researchers want to understand how this treatment influences things like body fat, how the body processes fats and sugars, growth patterns, bone health, and even emotional and social challenges.

Boys aged 10 to 14 with Klinefelter syndrome who meet certain health criteria may be eligible to participate. They will be randomly assigned to receive either testosterone treatment or a placebo (a non-active substance) for two years. Throughout the trial, participants will be monitored closely to see how the treatment impacts their development. It's important to know that this study is currently recruiting participants, and parental consent is required for anyone interested in joining.

Gender

MALE

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 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