NCT00984789已完成3 期
Transdermal Contraception Patch: EU Cycle Control Study Versus EVRA
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
- 393
- 主要终点
- Bleeding Patterns and cycle control
研究概览
简要总结
400 healthy women needed contraception will be asked to participate in this study. Half will be given EVRA, half will be given FC Patch low. They will be expected to apply the patches for 21 days of their cycle, for 7 cycles in total. The study will compare the patterns of menstrual bleeding on these two treatments, plus how effective they are at preventing pregnancy, general safety, and their acceptability to the participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women requesting contraception aged 18-35 years old
- •Smokers must not be older than 30 at time of informed consent
- •History of regular cyclic menstrual periods, normal cervical smear
排除标准
- •Pregnancy or lactation
- •Obesity (BMI>30), hypersensitivity to any ingredients of the study drug, significant skin reaction to transdermal preparations, any diseases/conditions that can compromise the functions of the body system (resulting in altered absorption/accumulation/ metabolism/excretion of the study drug), any diseases / conditions that may worsen under hormonal treatment
研究组 & 干预措施
Arm 1
Experimental
干预措施: Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016) (Drug)
Arm 2
Active Comparator
干预措施: Norelgestromin/Ethinylestradiol (EVRA) (Drug)
结局指标
主要结局
Bleeding Patterns and cycle control
时间窗: 7 cycles (each consisting of 28 days)
次要结局
- Contraceptive efficacy(7 cycles (each consisting of 28 days) + follow up period of 14 days)
- Adverse Event Collection(7 cycles (each consisting of 28 days))
- Population pharmacokinetics(7 cycles (each consisting of 28 days))
- Compliance to treatment(7 cycles (each consisting of 28 days))
- Subjective assessment of treatment(7 cycles (each consisting of 28 days))
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