Back to resultsOxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome
Primary Purpose
Turner's Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
growth hormone
oxandrolone
Sponsored by
About this trial
This is an interventional treatment trial for Turner's Syndrome focused on measuring Turner's syndrome, genetic diseases and dysmorphic syndromes, rare disease
Eligibility 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
Sites / Locations
- Jefferson Medical College of Thomas Jefferson University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004275
First Posted
October 18, 1999
Last Updated
September 8, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators
Jefferson Medical College of Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT00004275
Brief Title
Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome
Official Title
Phase II Randomized Study of Oxandrolone vs Placebo for Growth Hormone-Treated Girls With Turner's Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators
Jefferson Medical College of Thomas Jefferson University
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Turner's Syndrome
Keywords
Turner's syndrome, genetic diseases and dysmorphic syndromes, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
growth hormone
Intervention Type
Drug
Intervention Name(s)
oxandrolone
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith L Ross
Organizational Affiliation
Jefferson Medical College of Thomas Jefferson University
Official's Role
Study Chair
Facility Information:
Facility Name
Jefferson Medical College of Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5083
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome
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