NCT02362711已完成3 期
Phase3, Placebo Controlled, Randomized, Double-blinded, Long-Term, NSAID-Add-on, Clinical Trial of NPC-16 for Treatment of Dysmenorrhea
Nobelpharma0 个研究点目标入组 248 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 主要终点
- Patient Response to Treatment for Dysmenorrhea, as Evaluated by Total Dysmenorrhea Score
研究概览
简要总结
The purpose of this long-term study is to determine whether NPC-16 is effective in the treatment of dysmenorrhea.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •dysmenorrhea
排除标准
- •severe hepatopathy
- •pregnant woman
研究组 & 干预措施
NPC-16 Standard Dosing Regimen Group
Experimental
Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg
干预措施: NPC-16 Standard Dosing Regimen Group (Drug)
NPC-16 Continuous Dosing Regimen Group
Experimental
Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg
干预措施: NPC-16 Continuous Dosing Regimen Group (Drug)
Placebo Group
Placebo Comparator
Placebo for NPC-16
干预措施: Placebo Group (Drug)
结局指标
主要结局
Patient Response to Treatment for Dysmenorrhea, as Evaluated by Total Dysmenorrhea Score
时间窗: 52 weeks
次要结局
- Patient Response to Treatment for Dysmenorrhea, as Evaluated by Visual Analogue Scale (VAS) of Dysmenorrhea(52 weeks)
研究者
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