NCT00109512已完成2 期
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of NBI-56418 in 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
- 发起方
- Abbott
- 入组人数
- 76
- 试验地点
- 15
- 主要终点
- Total Composite Pelvic Signs and Symptom Scale (CPSSS) scores
研究概览
简要总结
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with subjects randomized to one of three treatment groups, placebo, 75 mg and 150 mg in a 1:1:1 ratio. Study drug was administered once daily for 12 weeks. After the last dose at the end of Week 12, follow-up continued every 4 weeks for 12 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: placebo (Drug)
NBI-56418 75 mg
Experimental
干预措施: NBI-56418 (GnRH antagonist) (Drug)
NBI-56418 150 mg
Experimental
干预措施: NBI-56418 (GnRH antagonist) (Drug)
结局指标
主要结局
Total Composite Pelvic Signs and Symptom Scale (CPSSS) scores
时间窗: Every 4 weeks
This scale is used to assess the signs (pelvic tenderness and induration) and symptoms (nonmenstrual pelvic pain, dysmenorrhea and dyspareunia) associated with endometriosis.
次要结局
- Endometriosis Health Profile-5 (EHP-5)(Every 4 weeks)
- Visual Analog Scale (VAS) scores(Every 4 weeks)
- Number of Subjects with Adverse Events(Up to 24 weeks)
- Clinical Laboratory Tests(Up to 24 weeks)
- Vital Sign Measurements(Up to 24 weeks)
- Physical Examinations(Up to 24 weeks)
- Electrocardiogram (ECG) tracings(Up to 24 weeks)
研究者
研究点 (15)
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