Androgen Effect on Klinefelter Syndrome Motor Outcome

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2017-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Klinefelter Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Oxandrolone

Androgen oxandrolone: Oxandrolone, 0.6 \> mg/kg/day, orally, for 2 years.

Group Type ACTIVE_COMPARATOR

androgen oxandrolone

Intervention Type DRUG

Oxandrolone ,06 \>mg/kg/day, orally, for 2 years

Placebo

An inactive substance.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

an inactive substance

Interventions

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androgen oxandrolone

Oxandrolone ,06 \>mg/kg/day, orally, for 2 years

Intervention Type DRUG

placebo

an inactive substance

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No