NCT00196365已完成3 期
A Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval Compared to Conventional Oral Contraceptive Therapy for Cyclic Pelvic Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Change from baseline in the clinical assessment of dysmenorrhea
研究概览
简要总结
This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe menstrual-related pain
- •Regular spontaneous menstrual cycles
排除标准
- •Any contraindication to the use of oral contraceptives
- •Treatment with an oral contraceptive in the last 3 months
- •Previous treatment failure with an extended oral contraceptive regimen
研究组 & 干预措施
1
Experimental
干预措施: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets (Drug)
2
Active Comparator
干预措施: levonorgestrel/EE 0.15/0.03 mg tablets and placebo (Drug)
结局指标
主要结局
Change from baseline in the clinical assessment of dysmenorrhea
时间窗: Baseline to Week 4,8,12,24, and 26 or early discontinuation
次要结局
- Analgesic use(Duration of study)
- Change from baseline in clinical assessment of dysmenorrhea (assessment of 4 additional symptoms)(Baseline to Weeks 4, 8, 12, 24 and 26 or early discontinuation)
- Incidence of menstrual bleeding and/or spotting(Duration of study)
研究者
研究点 (1)
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