Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome
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.
|Study Design:||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|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
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.
|United States, Pennsylvania|
|Jefferson Medical College of Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107-5083|
|Study Chair:||Judith L Ross||Jefferson Medical College of Thomas Jefferson University|