Status:
COMPLETED
Androgen Effect on Klinefelter Syndrome Motor Outcome
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Klinefelter Syndrome
Eligibility:
MALE
4-12 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effects of low-dose androgen on the motor and cognitive development of boys with Klinefelter syndrome.
Detailed Description
Klinefelter syndrome (KS), a genetic disorder that affects males only, is characterized by having an extra X chromosome. The phenotype - or physical and learning features - includes testicular failure...
Eligibility Criteria
Inclusion
- Karyotype diagnosis of Klinefelter syndrome
- Chronological age of 4-12 years
- No treatment with androgen in the past year
Exclusion
- Major liver, kidney or other systemic disease
- Variant karyotypes including 47,XYY males
- Evidence of spontaneous onset of puberty, defined as testicular size \> 4ml
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2017
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00348946
Start Date
July 1 2006
End Date
November 30 2017
Last Update
July 8 2021
Active Locations (1)
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1
Thomas Jefferson University, Department of Pediatrics, 1025 Walnut Street, Suite 726
Philadelphia, Pennsylvania, United States, 19107