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Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome

Turner's Syndrome Clinical Trial

Official title:
Phase II Randomized Study of Oxandrolone vs Placebo for Growth Hormone-Treated Girls With Turner's Syndrome

Clinical Trial Summary

RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X chromosome and do not produce the hormones estrogen and androgen. Giving growth hormone may help girls with Turner's syndrome attain a more normal height. It is not yet known if growth hormone is more effective with or without oxandrolone for Turner's syndrome.

PURPOSE: Randomized phase II trial to study the effectiveness of oxandrolone in girls who have growth hormone-treated Turner's syndrome.

Clinical Trial Description

PROTOCOL OUTLINE: This is a randomized study. Patients are randomly assigned to recombinant human growth hormone (GH) and oxandrolone versus GH and placebo.

GH is administered by daily subcutaneous injection and oxandrolone is given every day by mouth. Treatment continues for 3 years; estrogen is offered after year 2.

A study duration of 8 years is anticipated. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00004275
Study type Interventional
Source Office of Rare Diseases (ORD)
Contact
Status Completed
Phase Phase 2
Start date October 1999
View Details
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