An Open-Label Study to Evaluate Pharmacokinetic Profile of Agile TCDS AG200-15 and to Compare Exposure to Ethinyl Estradiol to Oral Contraceptive (Orthocyclen®) in Healthy Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Comparative Evaluation of Ethinyl Estradiol (EE) Cmax Between AG200-15 and Ortho-Cyclen® in Week 1
研究概览
简要总结
Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be evaluated.
详细描述
This is an open-label study comprised of two parts. Part I is a single-arm, run-in cycle with AG200-15 administered to all subjects as a 21-7 day regimen (three consecutive weeks of patch wear followed by a patch-free week).
Part II employs crossover design with subjects randomly assigned to one of the two treatment sequences. Each sequence will include AG200-15 and oral contraceptive (Ortho-Cyclen®) as described below: Sequence 1: AG200-15 (Period 1) followed by oral contraceptive, Ortho-Cyclen® (Period 2); Sequence 2: Oral contraceptive, Ortho-Cyclen® (Period 1) followed by AG200-15 (Period 2) Both AG200-15 and Ortho-Cyclen® will be administered as 21-7 day regimen (three consecutive weeks of drug-taking followed by a drug-free week). Duration of each treatment Period is 28 days (one cycle of therapy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Healthy women, ages 18-45
- •Body mass index (BMI) ≥18 and ≤32, and weight ≥ 110 lbs.
- •Willing to use a non-hormonal method of contraception if at risk of pregnancy, OR have already undergone previous bilateral tubal ligation or hysterectomy
- •Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior until completion of each treatment period
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
Ortho-Cyclen®
Ortho-Cyclen® is a comparator drug intervention
干预措施: Ortho-Cyclen (Drug)
AG200-15
AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention
干预措施: AG200-15 (Drug)
结局指标
主要结局
Comparative Evaluation of Ethinyl Estradiol (EE) Cmax Between AG200-15 and Ortho-Cyclen® in Week 1
时间窗: 3 months
Comparative evaluation of ethinyl estradiol (EE) Cmax between AG200-15 and Ortho-Cyclen® in week 1 for cycle 2 and 3.
Comparative Evaluation of EE AUC(0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 1
时间窗: 3 months
Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3.
Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 3
时间窗: 3 months
Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured.
Comparative Evaluation of EE Cmax Between AG200-15 and Ortho-Cyclen® in Week 3
时间窗: 3 months
Comparative evaluation of EE Cmax between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3.
Comparative Evaluation of EE AUC (0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 3
时间窗: 3 months
Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3.
Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 1
时间窗: 3 months
Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).
Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 1
时间窗: 3 months
Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured.
Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 3
时间窗: 3 months
Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).
Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 1
时间窗: 3 months
Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval).
Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 3
时间窗: 3 months
Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval).
Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3
时间窗: 3 months
Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3 for cycles 2 and 3.
Evaluation of LNG AUC (0-168hrs Post-first Dose) Between AG200-15 in Week 1 and 3
时间窗: 3 months
Evaluation of LNG AUC (0-168hrs post-first dose) Between AG200-15 in Week 1 and 3 for cycles 2 and 3.
Evaluation of LNG Css (1) Between AG200-15 in Week 1 and 3
时间窗: 3 months
Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen, steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).
次要结局
未报告次要终点