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Sponsors and Collaborators: |
Thomas Jefferson University National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00348946 |
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.
Condition | Intervention | Phase |
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Klinefelter Syndrome |
Drug: androgen oxandrolone Other: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Androgen Effect on Motor/Cognitive Outcome in Klinefelter Syndrome |
Estimated Enrollment: | 150 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | April 2014 |
Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: androgen oxandrolone
Oxandrolone or placebo capsule, .06 >mg/kg/day, orally, for 2 years
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2: Placebo Comparator |
Other: placebo
an inactive substance
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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.
Ages Eligible for Study: | 4 Years to 12 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Judith Ross, MD | 215-955-1648 | Judith.Ross@mail.tju.edu |
United States, Pennsylvania | |
Thomas Jefferson University, Department of Pediatrics, 1025 Walnut Street, Suite 726 | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Judith L. Ross, M.D. 215-955-1648 | |
Principal Investigator: Judith L. Ross, M.D. |
Principal Investigator: | Judith L. Ross, M.D. | Thomas Jefferson University |
Investigator: | Martha Zeger, M.D. | Thomas Jefferson University, Co-Investigator |
Responsible Party: | Thomas Jefferson University ( Judith L. Ross, MD, Principal Investigator, Professor, Department of Pediatrics ) |
Study ID Numbers: | R01NS050597-01A2 |
Study First Received: | July 3, 2006 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00348946 |
Health Authority: | United States: Food and Drug Administration |
Klinefelter syndrome androgen androgen oxandrolone |
Chromosomal abnormalities Gonadal Disorders Klinefelter Syndrome Chromosome Disorders Endocrine System Diseases Sex Differentiation Disorders Oxandrolone |
Urogenital Abnormalities Hypogonadism Genetic Diseases, Inborn Klinefelter syndrome Endocrinopathy Congenital Abnormalities |
Anabolic Agents Pathologic Processes Disease Syndrome Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Sex Chromosome Disorders Hormones Pharmacologic Actions Androgens |