Women With Epilepsy: a Pilot Study of PK and PD Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users

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

Visit 3/ Follow up 3 Weeks post IUS Insertion

• Vital Signs
• Phlebotomy for hormone and AED levels
• Transvaginal Ultrasound
• Review and collect completed diary
• Receive new diary

Visit 4/Follow up 3 Months post IUS Insertion

• Vital Signs
• Phlebotomy for hormone and AED levels
• Transvaginal ultrasound
• Review and collect completed diary
• Receive new diary
• Acceptability Questionnaire

Visit 5/ Exit 6 Months post IUS insertion

• Vital Signs
• Phlebotomy for hormone and AED levels
• Transvaginal Ultrasound
• Review and collect final completed diary
• Acceptability Questionnaire

Inclusion criteria

• 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

Exclusion criteria

• 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