NCT00338052已完成2 期
Open-Label Study of Cycle Control With Extended Administration of Norethindrone Acetate 1 mg / Ethinyl Estradiol 20 Mcg Oral Tablets
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 24
- 主要终点
- Number of bleeding/spotting days/episodes per treatment cycle
研究概览
简要总结
This is an non-comparative study. There is no statistical hypothesis. The effects of extension of treatment on bleeding will be recorded and described.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women
- •Age 25-40
- •History of regular cycles
排除标准
- •Current or recent (within 2 months) users of hormonal contraceptives
- •Contraindications for use of hormonal contraception
- •Conditions which affect the absorption or metabolism of steroid hormones
- •BMI > 35
结局指标
主要结局
Number of bleeding/spotting days/episodes per treatment cycle
次要结局
- Satisfaction
研究者
研究点 (24)
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