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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004275
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : September 10, 2008
Sponsor:
Collaborator:
Jefferson Medical College of Thomas Jefferson University
Information provided by:
Office of Rare Diseases (ORD)

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Turner's Syndrome Drug: growth hormone Drug: oxandrolone Phase 2

Detailed 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
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Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Jefferson Medical College of Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107-5083
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Jefferson Medical College of Thomas Jefferson University
Investigators
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Study Chair: Judith L Ross Jefferson Medical College of Thomas Jefferson University
More Information
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ClinicalTrials.gov Identifier: NCT00004275    
Other Study ID Numbers: 199/11681
TJU-11681
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: September 10, 2008
Last Verified: September 2008
Keywords provided by Office of Rare Diseases (ORD):
Turner's syndrome
genetic diseases and dysmorphic syndromes
rare disease
Additional relevant MeSH terms:
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Turner Syndrome
Gonadal Dysgenesis
Syndrome
Disease
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Sex Chromosome Disorders of Sex Development
Male Urogenital Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Hormones
Oxandrolone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgens
Anabolic Agents