Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using carbamazepine
研究概览
简要总结
Data on the interaction between the etonogestrel (ENG) implant and antiepileptic drug (AED) regimen are scarce. We will evaluated the effect of 2 AED regimens (1 including carbamazepine and the other topiramate) on the pharmacokinetic (PK) parameters of an ENG-releasing implant in women with epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women 18- 45 years old;
- •with regular menstrual cycles;
- •with BMI between 18 and 29.9 (kg/m2);
- •who has selected the ENG implant as a contraceptive method;
- •Using a stable antiepileptic drug regimen including carbamazepine or topiramate for ate least 3 months (only for women with epilepsy).
排除标准
- •use of short-acting hormonal contraceptives in the month prior to enrollment;
- •use of depomedroxyprogesterone acetate in the 6 months prior to enrollment;
- •women with conditions classified as category 3 and/or 4 for etonogestrel implant use according to the World Health Organization Medical Eligibility Criteria for contraceptive use;
- •drug or alcohol addiction;
- •use of other drugs metabolized by CYP3A4 30 days prior to enrollment;
- •non adherence to antiepileptic drug regimen (only for women with epilepsy);
- •illiteracy
研究组 & 干预措施
Implant
Women without epilepsy and not using an anti-epileptic drug will have an etonogestrel-releasing implant inserted
干预措施: Implant (Drug)
Carbamazepine-Implant
Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted
干预措施: Carbamazepine-Implant (Drug)
Topiramate-Implant
Women with epilepsy using topiramate for at least 3 months will have an etonogestrel-releasing implant inserted
干预措施: Topiramate-Implant (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using carbamazepine
时间窗: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for area under the curve evaluation of ENG (AUC, 0-24 weeks). The plasma ENG AUC will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.
Plasma maximum concentration (Cmax) of ENG in women with epilepsy (WWE) using carbamazepine
时间窗: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of plasma Cmax of ENG. The plasma ENG Cmax will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.
Plasma minimum concentration (Cmin) of ENG in women with epilepsy (WWE) using carbamazepine
时间窗: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of plasma Cmin of ENG. The plasma ENG Cmin will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.
Time to maximum concentration (Tmax) of ENG in women with epilepsy (WWE) using carbamazepine
时间窗: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of Tmax of ENG. The Tmax of ENG will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.
次要结局
- Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using topiramate(Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement)
- Plasma maximum concentration (Cmax) of topiramate in women with epilepsy (WWE)(Prior to implant placement and at 24 weeks of implant use)
- Plasma minimum concentration (Cmin) of topiramate in women with epilepsy (WWE) before and after ENG implant placement(Prior to implant placement and at 24 weeks of implant use)
- Time to maximum concentration (Tmax) of topiramate in women with epilepsy (WWE) before and after ENG implant placement(Prior to implant placement and at 24 weeks of implant use)
- Time to maximum concentration (Tmax) of ENG in women with epilepsy (WWE) using topiramate(Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement)
- Area under the plasma concentration versus time curve (AUC) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement(Prior to implant placement and at 24 weeks of implant use)
- Plasma minimum concentration (Cmin) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement(Prior to implant placement and at 24 weeks of implant use)
- Time to maximum concentration (Tmax) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement(Prior to implant placement and at 24 weeks of implant use)
- Bleeding pattern associated with etonogestrel implant use(Daily for 24 weeks)
- Plasma maximum concentration (Cmax) of ENG in women with epilepsy (WWE) using topiramate(Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement)
- Plasma minimum concentration (Cmin) of ENG in women with epilepsy (WWE) using topiramate(Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement)
- Plasma maximum concentration (Cmax) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement(Prior to implant placement and at 24 weeks of implant use)
- Area under the plasma concentration versus time curve (AUC) of topiramate in women with epilepsy (WWE) before and after ENG implant placement(Prior to implant placement and at 24 weeks of implant use)
研究者
Carolina Sales Vieira
Associate Professor, MD, PhD
University of Sao Paulo