Phase II Randomized Study of Oxandrolone vs Placebo for Growth Hormone-Treated Girls With Turner's Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供