A Study to Evaluate the Effects of Annovera™ and Tampon Co-Usage on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- The effect of Annovera and tampon co-use on area-under-the-curve (AUC) of Segesterone acetate and ethinyl estradiol (Days 2 to 3)
研究概览
简要总结
This study will evaluate the effect of Annovera and tampon co-usage on the pharmacokinetics (PK) of segesterone acetate (SA) and ethinyl estradiol (EE).
详细描述
This is an open label, randomized, crossover PK study. Participants will be randomized to one of two treatment sequences. Each treatment sequence consists of two cycles of treatment - one with tampon use and one without tampon use. Tampon use will occur on Days 2 to 5 of contraceptive vaginal system (CVS) use and a new CVS will be used for each treatment cycle. Before starting Annovera use, each subject will use a combined oral contraceptive (COC) for one cycle.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Annovera (alone)
Annovera without tampon use
干预措施: Segesterone Acetate and Ethinyl Estradiol (Drug)
Annovera with tampon use
Annovera with tampon use
干预措施: Segesterone Acetate and Ethinyl Estradiol (Drug)
Annovera with tampon use
Annovera with tampon use
干预措施: Tampon (Other)
结局指标
主要结局
The effect of Annovera and tampon co-use on area-under-the-curve (AUC) of Segesterone acetate and ethinyl estradiol (Days 2 to 3)
时间窗: Days 2 to 3
AUC for 24 hours
次要结局
- The effect of Annovera and tampon co-use on area-under-the-curve (AUC) of Segesterone acetate and ethinyl estradiol (Days 2 to 5)(Days 2 to 5)