A Drug-Drug Interaction Study to Evaluate the Effects of Strong CYP3A Induction and Inhibition on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol From the Annovera™ Contraceptive Vaginal System
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Area-under-the-curve (AUC) of rifampin and itraconzaole on Annovera (segesterone acetate and ethinyl estradiol)
研究概览
简要总结
A Drug-Drug Interaction (DDI) study to evaluate the effects of itraconazole and rifampin on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol from the Annovera Contraceptive Vaginal System (CVS)
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 with itraconazole use
Subjects will dose with 200 mg/day of itraconazole for five days before Annovera insertion and through Days 1 to 8 of Annovera use
干预措施: Itraconazole (Drug)
Annovera (alone)
Annovera taken alone (without itraconazole or rifampin)
干预措施: Segesterone Acetate and Ethinyl Estradiol (Drug)
Annovera with itraconazole use
Subjects will dose with 200 mg/day of itraconazole for five days before Annovera insertion and through Days 1 to 8 of Annovera use
干预措施: Segesterone Acetate and Ethinyl Estradiol (Drug)
Annovera with rifampin use
Subjects will dose with 600 mg/day rifampin for 8 days, between Days 4 to 11 of Annovera use during their respective treatment cycles
干预措施: Segesterone Acetate and Ethinyl Estradiol (Drug)
Annovera with rifampin use
Subjects will dose with 600 mg/day rifampin for 8 days, between Days 4 to 11 of Annovera use during their respective treatment cycles
干预措施: Rifampin (Drug)
结局指标
主要结局
Area-under-the-curve (AUC) of rifampin and itraconzaole on Annovera (segesterone acetate and ethinyl estradiol)
时间窗: Day 1 for itraconazole cohort, Day 11 for rifampin cohort
AUC for 24 hours for segesterone acetate and ethinyl estradiol
Maximum concentration (Cmax) of rifampin and itraconzaole on Annovera (segesterone acetate and ethinyl estradiol)
时间窗: Day 1 for itraconazole cohort, Day 11 for rifampin cohort
Cmax for segesterone acetate and ethinyl estradiol
次要结局
- Safety - Number of Participants with Adverse Events(Screening through 14 days following Annovera removal)
- Safety - Vital signs - systolic and diastolic blood pressure(Through study completion, an average of 4 months)
- Safety - Vital signs - pulse(Through study completion, an average of 4 months)
- Tolerability -Discontinuation rates(Through study completion, an average of 4 months)