Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on Clinical Trial of Mono-phase Low Dose Oral Contraceptive Pill for Treatment of Primary Dysmenorrhea.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 主要终点
- Patient Response to Treatment for Primary 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 combination oral contraceptive pill of norethindrone and ethinyl estradiol is effective in the treatment of primary 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, Care Provider, Investigator)
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
- •primary dysmenorrhea
排除标准
- •severe hepatopathy
- •pregnant woman
研究组 & 干预措施
IKH-01
ethinyl estradiol 0.035mg and norethisterone 1mg
干预措施: IKH-01 (Drug)
Placebo
Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
干预措施: Placebo (Drug)
结局指标
主要结局
Patient Response to Treatment for Primary 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-dnd of Treatment)(16weeks)