NCT02408445

Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Male
• Age: 42 Days – 108 Days
• Healthy volunteers: Not accepted

Summary

This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about body composition (muscle and fat) and male hormones and look at the effect of testosterone shots on body composition. The Investigators know that older boys and men with Klinefelter syndrome often have more fat compared to muscle than adults without Klinefelter syndrome, but we do not know if this difference is present at birth or develops over time. The Investigators will learn if body composition and motor skills are improved with testosterone treatment in infants with Klinefelter syndrome.

Conditions

• Klinefelter Syndrome

Interventions

Type	Name	Description
DRUG	testosterone cypionate 200mg/ml	Subjects in this group will be randomized to receive testosterone cypionate 200 mg/ml to be given intramuscularly every 4 weeks for a total of 3 doses.

Timeline

• Start date: 2015-05-08
• Primary completion: 2018-01-31
• Completion: 2020-01-01
• First posted: 2015-04-03
• Last updated: 2020-04-15
• Results posted: 2020-04-15

Locations

1 site across 1 country: United States