NCT00637182已完成3 期
An OptioExtension of Trial 1033US/0006 to Assess Safety, Tolerability, Efficacy of Anastrozole (ZD1033, Arimidex™) in Treatment of Gynecomastia in Pubertal Boys Given Placebo and to Conduct a Long-Term Safety Follow-Up of Non-Responding Subjects Given Anastrozole in the Previous Trial
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 主要终点
- Change in linear dimensions of the breast
研究概览
简要总结
The purpose of this study is to look at the effect of anastrozole (ZD1033, Arimidex™) in reducing gynecomastia in pubertal boys treated with placebo in Trial 1033US/0006 (another anastrozole study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects must have entered Trial 1033US/0006 and completed 6 months of treatment and one month of follow-up.
- •Subjects must have gynecomastia, with one breast measuring at least 3 cm in diameter.
排除标准
- •Subjects who have been given medications known to cause gynecomastia within the previous 3 months
结局指标
主要结局
Change in linear dimensions of the breast
次要结局
- Change in breast tenderness
研究者
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