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Clinical Trial: Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome
This study is no longer recruiting patients.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Turner's Syndrome | Drug: growth hormone Drug: oxandrolone | Phase II |
MedlinePlus related topics: Turner's Syndrome
Genetics Home Reference related topics: Turner syndrome
Study Type: Interventional
Study Design: Treatment, Placebo Control
Official Title: Phase II Randomized Study of Oxandrolone vs Placebo for Growth Hormone-Treated Girls with Turner's Syndrome
Expected Total Enrollment: 80
Study start: October 1999
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.
Eligibility
Ages Eligible for Study: 10 Years - 14 Years, Genders Eligible for Study: Female
Criteria
Location Information
Pennsylvania
Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania, 19107-5083, United States
Judith L Ross, Study Chair, Jefferson Medical College of Thomas Jefferson University
More Information
Record last reviewed: October 2003
Last Updated: October 13, 2004
Record first received: October 18, 1999
ClinicalTrials.gov Identifier: NCT00004275
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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