An Open-Label, Randomized, Phase 3 Study of the Contraceptive Efficacy and Safety of Agile Transdermal Contraceptive Delivery System in Comparison to an Oral Contraceptive (OC) Containing 150 mcg LNG and 30 mcg EE
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 407
- 主要终点
- Pregnancy Reported as Pearl Index
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, hormone related adverse events, lipid profile, 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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •sexually active women requesting contraception
- •Regular menses every 24 - 35 days
- •In good general health, confirmed by medical history, physical (including gynecologic examination adn 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
Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)
干预措施: AG200-15 (Drug)
Levora
oral contraceptive containing 150mcg of LNG and 30mcg of EE
干预措施: Levora (Drug)
结局指标
主要结局
Pregnancy Reported as Pearl Index
时间窗: 6 months
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
- Safety(6 months)