NCT00920985已完成3 期
Multi-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group Study to Evaluate Cycle Control, Bleeding Pattern, Blood Pressure, Lipid and Carbohydrate Metabolism of the Transdermal Contraceptive Patch (Material no. 80876395 / 2.1 mg Gestodene and 0.55 mg Ethinylestradiol) Versus an Oral Comparator Containing 20 µg Ethinylestradiol and 100 µg Levonorgestrel in a 21-day Regimen for 7 Cycles in 400 Women
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
- 346
- 主要终点
- Cycle control parameters and bleeding pattern indices
研究概览
简要总结
Birth Control Patch Study
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
- Double (Participant, Investigator)
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
- •Female subject requesting contraception
- •Age: 18 - 45 years (inclusive); smokers must not be older than 35 years at the time of informed consent
- •Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
- •History of regular cyclic menstrual periods
排除标准
- •Pregnancy or lactation
- •Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
- •Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
- •Use of other contraceptive methods than study medication
研究组 & 干预措施
Arm 1
Experimental
干预措施: Gestodene/EE (FC Patch Low, BAY86-5016) (Drug)
Arm 2
Active Comparator
干预措施: Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A (Drug)
结局指标
主要结局
Cycle control parameters and bleeding pattern indices
时间窗: Treatment cycles 2-7
次要结局
- Number of pregnancies while on treatment up to 14 days after removal of the last patch(7 treatment cycles each consisting of 28 days and follow-up period of 14 days)
- Evaluation of blood pressure changes during the dosing-free interval(7 treatment cycles each consisting of 28 days)
研究者
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