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

Epilepsy Clinical Trial

Official title: Women With Epilepsy: a Pilot Study of Pharmacokinetic and Pharmacodynamic Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Contraception
• Epilepsy

• NCT number: NCT02362373
• Study type: Interventional
• Source: Columbia University
• Status: Completed
• Phase: Phase 4
• Start date: August 2011
• Completion date: January 2014