NCT00391807已完成3 期
Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate 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
- 1,683
- 试验地点
- 1
- 主要终点
- Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, 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
- •BMI > 35
研究组 & 干预措施
study drug
Experimental
Norethindrone/Ethinyl Estradiol
干预措施: Norethindrone acetate/ethinyl estradiol (Drug)
结局指标
主要结局
Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,
时间窗: 13 cycles, 28 days each (1 year)
Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population
时间窗: 13 Cycles, 28 days each (1 year)
次要结局
- Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population(6 cycles, 28 days each (168 days))
- Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population(13 cycles, 28 days each (1 year))
- Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population(13 cycles, 28 days each (1 year))
- Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population(2 cycles, 28 days each (56 days))
- Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population(6 cycles, 28 days each (168 days))
- Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population(13 cycles, 28 days each (1 year))
- Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population(6 cycles, 28 days each (168 days))
- Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population(12 cycles, 28 days each (336 days))
- Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population(6 cycles, 28 days each (168 days))
- Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population(2 cycles, 28 days each (56 days))
- Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population(2 Cycles, 28 days each (56 days))
- Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population(2 cycles, 28 days each (56 days))
- Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population(13 cycles, 28 days each (1 year))
- Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population(6 cycles, 28 days each (168 days))
- Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population(2 cycles, 28 days each (56 days))
研究者
研究点 (1)
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