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

Turner's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004275
• Other study ID #: 199/11681
• Secondary ID: TJU-11681
• Status: Completed
• Phase: Phase 2
• First received: October 18, 1999
• Last updated: September 8, 2008
• Start date: October 1999

Study information

• Verified date: September 2008
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 14 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Primary Ovarian Insufficiency
• Syndrome
• Turner Syndrome
• Turner's Syndrome

Intervention

Drug:
• growth hormone

• oxandrolone

Locations

Country	Name	City	State
United States	Jefferson Medical College of Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)	Jefferson Medical College of Thomas Jefferson University

Country where clinical trial is conducted

United States,