NCT00362479已完成3 期
A Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021
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
- 1,347
- 试验地点
- 1
- 主要终点
- Evaluation of pregnancy rates
研究概览
简要总结
This is an open-label, single treatment study. All subjects will receive 6 months of oral contraceptive therapy with DR-1021. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.
详细描述
The overall study duration for each patient will be approximately 8 months, which includes a screening period of approximately 4 weeks; a treatment period of approximately six months (six,28-day cycles); and a follow-up visit approximately 4 weeks after completion of study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal
- •Not pregnant or breastfeeding
- •Sexually active at risk of pregnancy
排除标准
- •Any contraindication to the use of oral contraceptives
- •Pregnancy within the last 3 months
- •Smoking > 10 cigarettes per day
研究组 & 干预措施
1
Experimental
干预措施: DR-1021 (Drug)
结局指标
主要结局
Evaluation of pregnancy rates
时间窗: Duration of study
次要结局
- Adverse events reported by patients and investigators(Duration of study)
研究者
研究点 (1)
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