NCT00477633已完成3 期
An Open Label Study of the Contraceptive Efficacy of Norethindrone and Ethinyl Estradiol.
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
- 1,700
- 试验地点
- 1
- 主要终点
- Pearl Index, 18-35 Years, MITT Population
研究概览
简要总结
This is a non-comparative study. the primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.
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
- •Healthy Women
- •Age 18-45
- •At risk for pregnancy
- •History of regular cycles
排除标准
- •Contraindications for use of hormonal contraception
- •Conditions which affect the absorption or metabolism of steroid hormones
研究组 & 干预措施
Norethindrone/ethinyl estradiol
Experimental
1 tablet per day
干预措施: Norethindrone/ethinyl estradiol (Drug)
结局指标
主要结局
Pearl Index, 18-35 Years, MITT Population
时间窗: 13 cycles (28 days each), approximately 364 days
Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment
次要结局
- Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population(12 cycles (28 days each), approximately 336 days)
- Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population(12 cycles (28 days each), approximately 336 days)
研究者
研究点 (1)
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