NCT01533532已完成2 期
A Multicenter, Randomized, Placebo-controlled, Double-blind Phase II Study of KLH-2109 in Patients With Endometriosis(2)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The severity score of the pelvic pain
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.
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
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, medium dose
Experimental
干预措施: KLH-2109 (Drug)
KLH-2109, high dose
Experimental
干预措施: KLH-2109 (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
The severity score of the pelvic pain
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Phase II Randomized Open Label Study of KLH-2109 in Patients With EndometriosisEndometriosisNCT01629420Kissei Pharmaceutical Co., Ltd.20
已完成
2 期
A Randomized Open Label Study of KLH-2109 in Patients With Endometriosis(1)EndometriosisNCT01395940Kissei Pharmaceutical Co., Ltd.20
已完成
3 期
A Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1Complex Regional Pain Syndrome, Type 1NCT00166452Mayo Clinic7
已完成
2 期
Late Phase II Clinical Study of KLH-2109 in Patients With EndometriosisEndometriosisNCT02778919Kissei Pharmaceutical Co., Ltd.
已完成
3 期
A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and PainUterine Fibroids (MeSH Heading: Leiomyoma)NCT05445167Kissei Pharmaceutical Co., Ltd.89