NCT00004275

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

Phase II Randomized Study of Oxandrolone vs Placebo for Growth Hormone-Treated Girls With Turner's Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (planned)
• Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) · NIH
• Sex: Female
• Age: 10 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Turner's Syndrome

Interventions

Type	Name	Description
DRUG	growth hormone
DRUG	oxandrolone

Timeline

• Start date: 1999-10-01
• Primary completion: 2007-08-01
• First posted: 1999-10-19
• Last updated: 2008-09-10

Locations

1 site across 1 country: United States