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| Sponsors and Collaborators: |
National Institute of Neurological Disorders and Stroke (NINDS) Jefferson Medical College of Thomas Jefferson University |
|---|---|
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004275 |
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 | Intervention | Phase |
|---|---|---|
|
Turner's Syndrome |
Drug: growth hormone Drug: oxandrolone |
Phase II |
| 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 |
| Estimated Enrollment: | 80 |
| Study Start Date: | October 1999 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
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 to 14 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
Turner's syndrome-compatible karyotype No Y material in peripheral karyotype Bone age no greater than 11 years --Prior/Concurrent Therapy-- No more than 12 months of prior estrogen, androgen, or growth hormone
Contacts and Locations| United States, Pennsylvania | |
| Jefferson Medical College of Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107-5083 | |
| Study Chair: | Judith L Ross | Jefferson Medical College of Thomas Jefferson University |
More Information
| Study ID Numbers: | 199/11681, TJU-11681 |
| Study First Received: | October 18, 1999 |
| Last Updated: | September 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004275 History of Changes |
| Health Authority: | United States: Federal Government |
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Turner's syndrome genetic diseases and dysmorphic syndromes rare disease |
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Gonadal Disorders Hormone Antagonists Genital Dwarfism Hormones, Hormone Substitutes, and Hormone Antagonists Rare Diseases Chromosome Disorders Endocrine System Diseases Ovarian Dwarfism Hormones Sex Differentiation Disorders |
Monosomy X Oxandrolone Turner Syndrome Anabolic Agents Urogenital Abnormalities Genetic Diseases, Inborn Endocrinopathy Congenital Abnormalities Androgens Gonadal Dysgenesis |
|
Disease Gonadal Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Chromosome Disorders Endocrine System Diseases Hormones Sex Differentiation Disorders Pharmacologic Actions Oxandrolone |
Turner Syndrome Anabolic Agents Pathologic Processes Urogenital Abnormalities Genetic Diseases, Inborn Syndrome Sex Chromosome Disorders Congenital Abnormalities Androgens Gonadal Dysgenesis |
