Women With Epilepsy: a Pilot Study of PK and PD Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users
Condition: Epilepsy; Contraception
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): levonorgestrel IUS
Intervention type(s): Drug
Intervention description(s): placement of levonorgestrel intrauterine system
Other intervention name(s): Mirena
Intervention MeSH terms: Levonorgestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: epilepsy; contraception; drug interaction