NCT00819312已完成3 期
A Multicenter, Open-label, Single-arm Study to Investigate the Efficacy and Safety of the Oral Contraceptive YAZ (20 μg Ethinylestradiol, 3 mg Drospirenone) for 13 Cycles in 670 Healthy Chinese Female Volunteers.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 675
- 主要终点
- The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women.
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 between 18 and 45 requesting oral contraception.
- •Smokers may not exceed 30 years of age.
排除标准
- •The use of steroidal oral contraceptives , or any drug that could alter oral contraception metabolism will be prohibited during the study.
- •Pregnancy, lactation (less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment)
- •Menstrual disorders suspicious of ovarian failure (e.g. oligomenorrhea, amenorrhea, hypomenorrhea
- •Any disease or condition that may worsen under hormonal treatment
- •Other contraceptive methods such as sterilization or IUD/IUS
- •Substantial overweight (BMI > 30 kg/m2).
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: YAZ (SH T00186, BAY86-5300) (Drug)
结局指标
主要结局
The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment.
时间窗: 13 cycles (1 cycle= 28 days)
次要结局
- Laboratory tests(Whole study period)
- Bleeding pattern indices(13 cycles)
- Cycle control parameters(13 cycles)
- Adverse events(Whole study period)
研究者
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