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
Intervention: levonorgestrel IUS
Intervention description: placement of levonorgestrel intrauterine system
Intervention MeSH terms: Levonorgestrel
Phase: Phase 4
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: epilepsy; contraception; drug interaction

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age18-45 years

          2. Regular menstrual cycle of length 21-35 days

          3. Willing to use IUS for contraception

          4. Willing to use non-hormonal contraception for one month before insertion

          5. Stable AED therapy for at least two months

          6. Well-controlled epilepsy (2 or fewer seizures, other than simple partial, per month)

          7. Working telephone

          8. English Speaking

        Exclusion Criteria:

          1. Current pregnancy or pregnancy in the previous two months

          2. Breastfeeding with amenorrhea

          3. Hepatic p450 enzyme inducing medications other than AEDs (griseofulvin, rifampin, St.
             John's Wort, bosentan)

          4. Depomedroxyprogesterone acetate within previous six months

          5. Congenital or acquired uterine anomaly, including myomas, that distort the uterine
             cavity

          6. Acute pelvic infection or a history pelvic infection without subsequent intrauterine
             pregnancy

          7. Postpartum endometritis or infected abortion in the last three months

          8. Genital bleeding of unknown etiology

          9. Untreated lower genital tract infection (cervical or vaginal)

         10. Acute liver disease or liver tumor, benign or malignant

         11. HIV infection or partner with HIV infection

         12. Increased susceptibility to pelvic infection

         13. A previously inserted intrauterine device (IUD) that has not been removed

         14. Hypersensitivity to any component of the LNG IUS

         15. Known or suspected carcinoma of the breast

         16. 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

         17. History of genital tract malignancy

         18. Current use of anti-coagulants

         19. Current alcoholism or drug abuse