Androgen Effect on Klinefelter Syndrome Motor Outcome
|ClinicalTrials.gov Identifier: NCT00348946|
Recruitment Status : Active, not recruiting
First Posted : July 6, 2006
Last Update Posted : October 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Klinefelter Syndrome||Drug: androgen oxandrolone Other: placebo||Phase 2|
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, tall stature, and specific cognitive and behavioral attributes such as diminished motor function, language-based learning difficulties, poor self-image, and shyness. The KS phenotype may be the result of androgen deficiency in utero, infancy, and childhood. For individuals with KS, androgen replacement is standard treatment in adolescence and adulthood but has not been used earlier in childhood or included in the standard medical care of KS children ages 4 to 12.
The purpose of this study is to examine the effects of androgen on learning and development in boys with KS. Researchers also want to determine if low-dose androgen replacement at an early age will improve some of the learning difficulties associated with the disorder. The overall goal of this study is to address questions regarding the relationship of early androgen deficiency to learning and motor function.
Participants in the study will be randomized to one of two treatment groups, receiving either oxandrolone (low-dose androgen) or placebo, for two years. All participants will be evaluated for safety at the beginning of the study and at 3, 6, 12, 18, and 24 months. Also at the beginning of the study and every 3 to 6 months thereafter (for a total of 6 visits), the researchers will perform a careful history and physical examination and a bone age X-ray, and obtain a blood sample.
Participation in the trial will last two years and includes 6 clinic visits.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Androgen Effect on Motor/Cognitive Outcome in Klinefelter Syndrome|
|Study Start Date :||July 2006|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
|Active Comparator: 1||
Drug: androgen oxandrolone
Oxandrolone or placebo capsule, .06 >mg/kg/day, orally, for 2 years
|Placebo Comparator: 2||
an inactive substance
- Evaluation of several aspects of motor function including muscle strength, motor response speed, simple repetitive movement, and complex nonrepetitive motor action, previously shown to be impaired in boys with Klinefelter syndrome. [ Time Frame: 2 years per subject ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348946
|United States, Pennsylvania|
|Thomas Jefferson University, Department of Pediatrics, 1025 Walnut Street, Suite 726|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Judith L. Ross, M.D.||Thomas Jefferson University|