Phase II Randomized Study of Oxandrolone vs Placebo for Growth Hormone-Treated Girls With Turner's Syndrome
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 10 Years to 14 Years (Child)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion 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
Exclusion Criteria
- Not provided