The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Serum Etonogestrel Concentrations
研究概览
简要总结
A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum Etonogestrel (ENG) levels in contraceptive implant users.
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
- 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, who have had an ENG implant for 12-36 months at the time of enrollment;
- •Will maintain their implant during the study without modifications.
排除标准
- •Women who are taking any medications or supplements known to be
- •Cytochrome P-450 enzyme inducers, inhibitors, or substrates, and
- •are not willing to abstain from any of these medications or supplements during the entire course of the study.
- •Women with liver disease (i.e. hepatitis, fatty liver disease), and
- •Women with abnormal liver or renal function, or
- •Women with abnormal electrolytes on their screening blood work.
研究组 & 干预措施
ENG Implant Users
Healthy women using an ENG implant for at least 12 months and no greater than 36 months will be administered a 6 week titration schedule of topiramate to a max dose of 200mg bid by the final week.
干预措施: Topiramate (Drug)
结局指标
主要结局
Serum Etonogestrel Concentrations
时间窗: Enrollment (Baseline), 4 weeks (Visit 2), 5 weeks (Visit 3), 6 weeks (Visit 4)
The investigators will collect serum from participants at enrollment and at each of the three study follow-up visits. All samples will be batched for analysis. Analysis will be performed using a liquid-chromatography mass-spectrometry validated assay for measurement of serum etonogestrel concentration.
次要结局
未报告次要终点