Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 215
- 主要终点
- Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)
研究概览
简要总结
The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.
详细描述
The main objective of this study is to confirm the effectiveness and safety profile of NPC-01 in comparison with placebo in the treatment of dysmenorrhea (primary and secondary dysmenorrhea).
Additionally we also investigate the differences of effectiveness of NPC-01 in comparison with IKH-01 in the treatment of secondary dysmenorrhea as a reference, because IKH-01 is already marketed at them.
To achieve these, closed testing procedure is used in this study. After confirming statistical differences between NPC-01 and Placebo in the total dysmenorrhea, stratified analysis is carried out for primary dysmenorrhea (NPC-01, Placebo), and secondary dysmenorrhea (NPC-01, IKH-01 and Placebo).
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-01
Norethisterone 1mg, Ethinyl estradiol 0.02mg
干预措施: NPC-01 (Drug)
IKH-01
Norethisterone 1mg, Ethinyl estradiol 0.035mg
干预措施: IKH-01 (Drug)
Placebo
Placebo for NPC-01
干预措施: Placebo (Drug)
结局指标
主要结局
Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)
时间窗: 16weeks
The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days
次要结局
- Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment)(16weeks)