Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome
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|ClinicalTrials.gov Identifier: NCT00004275|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : September 10, 2008
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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 or disease||Intervention/treatment||Phase|
|Turner's Syndrome||Drug: growth hormone Drug: oxandrolone||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||80 participants|
|Official Title:||Phase II Randomized Study of Oxandrolone vs Placebo for Growth Hormone-Treated Girls With Turner's Syndrome|
|Study Start Date :||October 1999|
|Actual Primary Completion Date :||August 2007|
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|Ages Eligible for Study:||10 Years to 14 Years (Child)|
|Sexes 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004275
|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|
|Other Study ID Numbers:||
|First Posted:||October 19, 1999 Key Record Dates|
|Last Update Posted:||September 10, 2008|
|Last Verified:||September 2008|
genetic diseases and dysmorphic syndromes
Disorders of Sex Development
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Sex Chromosome Disorders of Sex Development
Male Urogenital Diseases
Heart Defects, Congenital
Sex Chromosome Disorders
Genetic Diseases, Inborn
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs