Women With Epilepsy: a Pilot Study of PK and PD Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
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.