Women With Epilepsy: a Pilot Study of Pharmacokinetic and Pharmacodynamic Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percent of Participants That Experienced Clinically Meaningful Change in Lamotrigine Level
研究概览
简要总结
The investigators will conduct a prospective, seven-month pilot study to explore pharmacokinetic (PK) and pharmacodynamic (PD) effects among women with epilepsy using the levonorgestrel intrauterine system (LNG IUS) for contraception. The investigators will enroll twenty women with well-controlled epilepsy maintained on stable anti-epileptic drugs (AED) therapy seeking the LNG IUS for contraception. The primary outcomes are AED levels and seizures before and after LNG IUS placement. Secondary outcomes include LNG levels, evidence of ovulation three weeks after insertion (serum progesterone >3ng/ml), bleeding and spotting, endometrial thickness, continuation, satisfaction and adverse events (removals, expulsions, side effects). The investigators will conduct a baseline month assessment, insertion visit, and follow-up visits at 21 days, three months and six months.
详细描述
Study Procedures This pilot study consists of five study visits. Once preliminary eligibility is determined through a telephone screening interview, the first visit is scheduled.
Visit 1 Enrollment/Baseline
- Review Eligibility
- Informed Consent
- Collect Baseline Information
- Vital Signs
- Pregnancy Test
- Complete Physical Exam including Pelvic exam,
- Chlamydia testing, and a Pap test if needed as per ASCCP (American Society for Colposcopy and Cervical Pathology) guidelines
- Receive diary to record any bleeding or spotting
- Receive condoms, if needed, for use until IUS insertion
- Sign release for contact of primary neurologist or epileptologist
- Study MD to contact participant's neurologist to notify of trial participation, and verify type and dose of AEDs
Visit 2 Insertion/4-6 Weeks from Baseline
- Vital Signs
- Pregnancy Test
- Phlebotomy for hormone and AED levels
- Transvaginal ultrasound
- IUS Insertion
- Review and collect completed diary
- Receive new diary
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Age18-45 years
- •Regular menstrual cycle of length 21-35 days
- •Willing to use IUS for contraception
- •Willing to use non-hormonal contraception for one month before insertion
- •Stable AED therapy for at least two months
- •Well-controlled epilepsy (2 or fewer seizures, other than simple partial, per month)
- •Working telephone
- •English Speaking
排除标准
- •Current pregnancy or pregnancy in the previous two months
- •Breastfeeding with amenorrhea
- •Hepatic p450 enzyme inducing medications other than AEDs (griseofulvin, rifampin, St. John's Wort, bosentan)
- •Depomedroxyprogesterone acetate within previous six months
- •Congenital or acquired uterine anomaly, including myomas, that distort the uterine cavity
- •Acute pelvic infection or a history pelvic infection without subsequent intrauterine pregnancy
- •Postpartum endometritis or infected abortion in the last three months
- •Genital bleeding of unknown etiology
- •Untreated lower genital tract infection (cervical or vaginal)
- •Acute liver disease or liver tumor, benign or malignant
- •HIV infection or partner with HIV infection
- •Increased susceptibility to pelvic infection
- •A previously inserted intrauterine device (IUD) that has not been removed
- •Hypersensitivity to any component of the LNG IUS
- •Known or suspected carcinoma of the breast
- •Current abnormal cervical cytology other than ASCUS or a history of abnormal cervical cytology other than ASCUS without appropriate follow-up demonstrating no evidence of disease
- •History of genital tract malignancy
- •Current use of anti-coagulants
- •Current alcoholism or drug abuse
研究组 & 干预措施
levonorgestrel IUS
all women in the study underwent placement of the levonorgestrel IUS in an open-label fashion, outcomes were compared before and after placement.
干预措施: levonorgestrel IUS (Drug)
结局指标
主要结局
Percent of Participants That Experienced Clinically Meaningful Change in Lamotrigine Level
时间窗: from baseline to 6 months after LNG IUS insertion
The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of lamotrigine after IUD insertion.
Percent of Participants That Experienced Clinically Meaningful Change in Levetiracetam Level
时间窗: from baseline to 6 months after LNG IUS insertion
The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of levetiracetam after IUD insertion.
Percent of Participants That Experienced Clinically Meaningful Change in Oxcarbazepine Level
时间窗: from baseline to 6 months after LNG IUS insertion
The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of oxcarbazepine after IUD insertion.
次要结局
- Change in Seizure Frequency(baseline to 6 months)
- Number of Participants Continuing With IUD(6 months)
研究者
Anne Davis
Associate Professor of Clinical Obstetrics and Gynecology
Columbia University