Open-label, Randomized, Parallel Group, Study of Efficacy and Safety of a Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-dose Oral Contraceptive Containing 0.02 mg EE and 0.1 mg LNG in a 21-day Regimen.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,504
- 试验地点
- 2
- 主要终点
- Pregnancy
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
详细描述
Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).
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
- 17 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy females
- •17(in states where the legal age of consent to receive contraceptives is 17)-40 years
- •Regular, consistent menstrual cycles between 25 and 35 days
- •Sexually active women requesting birth control
- •In good general health, confirmed by medical history, physical (including gynecologic) examination and screening laboratory values
排除标准
- •Known or suspected pregnancy;
- •Lactating women
- •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
AG200-15 (cycles 1-13)
AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug.
干预措施: AG200-15 (cycles 1-13) (Drug)
Lessina crossover to AG200-15
Lessina containing ethinyl estradiol and levonorgestrel for 6 cycles followed by AG200-15 for 6 cycles. Type of intervention is drug.
干预措施: Lessina crossover to AG200-15 (Drug)
结局指标
主要结局
Pregnancy
时间窗: AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year
Pregnancy outcomes was determine by measuring Pearl index. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.
次要结局
未报告次要终点