Androgen Effect on Klinefelter Syndrome Motor Outcome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Thomas Jefferson University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00348946
First received: July 3, 2006
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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
Klinefelter Syndrome
Drug: androgen oxandrolone
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Androgen Effect on Motor/Cognitive Outcome in Klinefelter Syndrome

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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
Active Comparator: 1 Drug: androgen oxandrolone
Oxandrolone or placebo capsule, .06 >mg/kg/day, orally, for 2 years
Placebo Comparator: 2 Other: placebo
an inactive substance

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, 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.

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Karyotype diagnosis of Klinefelter syndrome
  • Chronological age of 4-12 years
  • No treatment with androgen in the past year

Exclusion Criteria:

  • Major liver, kidney or other systemic disease
  • Variant karyotypes including 47,XYY males
  • Evidence of spontaneous onset of puberty, defined as testicular size > 4ml
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348946

Locations
United States, Pennsylvania
Thomas Jefferson University, Department of Pediatrics, 1025 Walnut Street, Suite 726
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Judith L. Ross, M.D. Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00348946     History of Changes
Other Study ID Numbers: R01NS050597-01A2
Study First Received: July 3, 2006
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:
Klinefelter syndrome
androgen
androgen oxandrolone

Additional relevant MeSH terms:
Syndrome
Klinefelter Syndrome
Disease
Pathologic Processes
Sex Chromosome Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Hypogonadism
Androgens
Oxandrolone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anabolic Agents

ClinicalTrials.gov processed this record on September 22, 2014