NCT02778919已完成2 期
Late Phase II Clinical Study of KLH-2109 in Patients With Endometriosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 主要终点
- Change of average Numerical Rating Scale (NRS) score of pelvic pain
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and dose-response relationship of KLH-2109 compared to placebo in Japanese patients with endometriosis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with endometriosis
排除标准
- •Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
研究组 & 干预措施
KLH-2109, low dose
Experimental
干预措施: KLH-2109 (Drug)
KLH-2109, lowest dose
Experimental
干预措施: KLH-2109 (Drug)
KLH-2109, lowest dose
Experimental
干预措施: Placebo (Drug)
KLH-2109, low dose
Experimental
干预措施: Placebo (Drug)
KLH-2109, medium dose
Experimental
干预措施: KLH-2109 (Drug)
KLH-2109, medium dose
Experimental
干预措施: Placebo (Drug)
KLH-2109, high dose
Experimental
干预措施: KLH-2109 (Drug)
Placebo
Placebo Comparator
First 12 week period; Placebo, Second 12 week period; randomize to one of the KLH-2109 dose levels
干预措施: Placebo (Drug)
Leuprorelin acetate
Other
Active reference
干预措施: Leuprorelin acetate (Drug)
结局指标
主要结局
Change of average Numerical Rating Scale (NRS) score of pelvic pain
时间窗: 12 weeks
次要结局
- Incidences of adverse events(24 weeks)
研究者
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