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Androgen Effect on Klinefelter Syndrome Motor Outcome

NCT00348946 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2021-07-08

Study results available
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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.

Conditions

  • Klinefelter Syndrome

Interventions

DRUG

androgen oxandrolone

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

OTHER

placebo

an inactive substance

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Judith L. Ross, M.D. · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00348946 on ClinicalTrials.gov