NCT00233610已完成3 期
A Comparative Trial of the Efficacy of Two Different Nolvadex (NDX) Dosing and Scheduling Regimens in Preventing Gynecomastia Induced by Casodex (CDX) 150 Monotherapy in Prostate Cancer Patients. An Open, Multicenter, Phase III 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
- 入组人数
- 180
- 试验地点
- 11
- 主要终点
- Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.
研究概览
简要总结
The aim of the study is to investigate the efficacy of different dosing and scheduling of Nolvadex in preventing gynecomastia/mastalgia induced by Casodex 150 mg monotherapy in patients with prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed prostate cancer
- •Locally advanced prostate cancer patients suitable for Casodex 150 mg monotherapy
排除标准
- •Age > 75 yrs
- •No metastatic disease (M1).
- •No presence of gynaecomastia and/or mastalgia at screening
- •No therapy with medications able to provoke gynaecomastia and/or mastalgia within 6 months of trial entry.
结局指标
主要结局
Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.
次要结局
- Sexual functioning, Quality of life.
研究者
研究点 (11)
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