NCT00212342已完成3 期
Phase 3,Placebo Controlled,Randomized,Double-Blinded,NSAID-Add-on,Clinical Trial of Mono-phase Low Dose Oral Contraceptive Pill for Treatment of Dysmenorrhea Associated With Endometriosis.
Nobelpharma0 个研究点目标入组 100 人开始时间: 2004年12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
- 100
- 主要终点
- patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS
研究概览
简要总结
The purpose of this study is to determine whether combination oral contraceptive pill of Norethindrone & Ethinyl estradiol is effective in the treatment of dysmenorrhea associated 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •dysmenorrhea associated with endometriosis
排除标准
- •severe hepatopathy
- •pregnant woman
研究组 & 干预措施
Norethisterone,Ethinylestradiol
Experimental
干预措施: Norethisterone,Ethinylestradiol (Drug)
Sugar pill
Placebo Comparator
干预措施: Sugar pill (Drug)
结局指标
主要结局
patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS
次要结局
- changes in the VAS of dysmenorrhea.
- changes in the VRS of non-menstrual pain.
- changes in the VAS of non-menstrual pain.
- changes in the clinical evaluation of pelvic induration.
- changes in the size of ovarian endometrioma.
研究者
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招募中
不适用
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