A Single-arm, Open-label, Multicenter Phase 3 Study of the Contraceptive Efficacy, Safety and Tolerability of the AG200-15 Transdermal Contraceptive Delivery System (TCDS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,032
- 主要终点
- Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset.
研究概览
简要总结
Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.
详细描述
AG200-15 is used in a 4-week (28-day) treatment cycle: a patch is applied and replaced every 7 days for 3 consecutive weeks, followed by a 1-week "patch-free" period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy, sexually active woman at risk for pregnancy seeking to use hormonal contraception for at least 1 year
- •Ability to demonstrate willingness to participate and adhere to study protocol
排除标准
- •Known or suspected pregnancy
- •Lactating women
- •Anticipates use of condoms or any other form of back-up contraception during the study
- •History of dermal sensitivity to medicated patches (nicotine) or to bandages, surgical tape, etc.
- •Has a contraindication to combined estrogen-progestin contraceptive use
- •Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
- •Smoker who is 35 years old or over
研究组 & 干预措施
AG200-15
AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)
干预措施: AG200-15 (Drug)
结局指标
主要结局
Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset.
时间窗: 1 year
The Pearl Index will serve as the primary contraceptive efficacy endpoint for evaluation of pregnancy rates for the study. 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
- Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 25 kg/m2, ITT Dataset(1 year)
- Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 25 and < 30 kg/m2, ITT Dataset(1 year)
- Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 30 kg/m2, ITT Dataset(1 year)