A Dose-ranging Clinical Trial to Study the Efficacy and Safety of DR-2031 for the Treatment of Hot Flashes Following Surgical or Medical Castration of Prostate Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 3
- 主要终点
- Identify the lowest effective dose.
研究概览
简要总结
This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as "add-on" therapy for prostate cancer patients with hot flashes following surgical or medical castration. All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study. Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period.
详细描述
This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as "add-on" therapy for prostate cancer in patients with mild to moderate vasomotor symptoms (hot flashes) following surgical or medical castration. All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study. To be eligible for this study prostate cancer patients must have undergone bilateral orchiectomy or medical castration utilizing LHRH analogues (LHRH agonists or LHRH antagonists) with or without additional antiandrogen therapy. Patients must have at least 21 moderate to severe hot flashes weekly.
Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period. In addition, a brief physical evaluation will be done, diaries will be reviewed and any adverse events will be recorded at each follow-up evaluation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer patients who have undergone chemical or surgical castration
- •History of hot flashes for at least 30 days
- •Stable prostate cancer therapy for at least 45 days
排除标准
- •Uncontrolled diabetes or severe COPD
- •History of thromboembolic disease
- •Liver or kidney dysfunction
- •History or presence of cancer other than prostate cancer within the last 5 years
- •Surgery within the last 3 months
研究组 & 干预措施
Cyproterone acetate 5 mg ( DR-2031)
1 tablet daily
干预措施: Cyproterone acetate 5 (Drug)
Cyproterone acetate 15 mg ( DR-2031)
1 tablet daily
干预措施: Cyproterone acetate 15 (Drug)
Cyproterone acetate 25 mg ( DR-2031)
1 tablet daily
干预措施: Cyproterone acetate 25 (Drug)
Placebo
1 tablet daily
干预措施: Placebo (Drug)
结局指标
主要结局
Identify the lowest effective dose.
时间窗: End of study
To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes
时间窗: Throughout study
To evaluate the safety compared to placebo
时间窗: Throughout study
次要结局
- To compare the efficacy in elimination of all hot flashes(Throughout study)
- To compare the efficacy in reducing the severity of all hot flashes(Throughout study)