The Effects of Androgen, Estrogen, and the Combination of Androgen and Estrogen on Growth Rate and Cognitive Function of Growth Hormone-treated Girls With Turner Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Cognitive function in girls with Turner Syndrome
研究概览
简要总结
The purposes of this study are to learn whether treatment with an androgen type hormone will improve the visual-spatial problems associated with Turner syndrome, and to evaluate the effect growth hormone, with and without androgen, has on growth.
详细描述
Turner syndrome is associated with short stature, multiple physical stigmata, absent pubertal development, and increased learning problems. This study is designed to (1) examine the effects of sex steroids (androgen and estrogen) on multiple variables including growth rate, GH binding protein, IGF-I, IGFBP3, and cognitive function in the setting of supplemental growth hormone administration and (2) to investigate any synergistic or additive effects of the androgen and estrogen combination versus each alone, on the above variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
研究组 & 干预措施
1
干预措施: estrogen (Drug)
1
干预措施: androgen (Drug)
2
干预措施: estrogen (Drug)
2
干预措施: placebo (Other)
结局指标
主要结局
Cognitive function in girls with Turner Syndrome
时间窗: 4 years
次要结局
未报告次要终点