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

December 14, 2015 updated by: Anne Davis, Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: levonorgestrel IUS
all women in the study underwent placement of the levonorgestrel IUS in an open-label fashion, outcomes were compared before and after placement.
Drug: levonorgestrel IUS
placement of levonorgestrel intrauterine system
Other Names:
  • Mirena

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Participants That Experienced Clinically Meaningful Change in Lamotrigine Level
Time Frame: from baseline to 6 months after LNG IUS insertion
The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of lamotrigine after IUD insertion.
from baseline to 6 months after LNG IUS insertion
Percent of Participants That Experienced Clinically Meaningful Change in Levetiracetam Level
Time Frame: from baseline to 6 months after LNG IUS insertion
The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of levetiracetam after IUD insertion.
from baseline to 6 months after LNG IUS insertion
Percent of Participants That Experienced Clinically Meaningful Change in Oxcarbazepine Level
Time Frame: from baseline to 6 months after LNG IUS insertion
The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of oxcarbazepine after IUD insertion.
from baseline to 6 months after LNG IUS insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Seizure Frequency
Time Frame: baseline to 6 months
Number of participants with increased, unchanged or decreased mean monthly seizure frequency.
baseline to 6 months
Number of Participants Continuing With IUD
Time Frame: 6 months
Women continuing the IUD for contraception at 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

February 9, 2015

First Posted (Estimate)

February 12, 2015

Study Record Updates

Last Update Posted (Estimate)

January 18, 2016

Last Update Submitted That Met QC Criteria

December 14, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAI0750

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

Clinical Trials on levonorgestrel IUS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe