Women With Epilepsy: a Pilot Study of PK and PD Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users (WESAIL)
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ClinicalTrials.gov Identifier: NCT02362373 |
Recruitment Status :
Completed
First Posted : February 12, 2015
Results First Posted : January 18, 2016
Last Update Posted : January 18, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epilepsy Contraception | Drug: levonorgestrel IUS | Phase 4 |
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 (Clinical Trial) |
Actual Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | Women With Epilepsy: a Pilot Study of Pharmacokinetic and Pharmacodynamic Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | January 2014 |

Arm | Intervention/treatment |
---|---|
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.
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Drug: levonorgestrel IUS
placement of levonorgestrel intrauterine system
Other Name: Mirena |
- 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.
- 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.
- 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.
- Change in Seizure Frequency [ Time Frame: baseline to 6 months ]Number of participants with increased, unchanged or decreased mean monthly seizure frequency.
- Number of Participants Continuing With IUD [ Time Frame: 6 months ]Women continuing the IUD for contraception at 6 months

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age18-45 years
- Regular menstrual cycle of length 21-35 days
- Willing to use IUS for contraception
- Willing to use non-hormonal contraception for one month before insertion
- Stable AED therapy for at least two months
- Well-controlled epilepsy (2 or fewer seizures, other than simple partial, per month)
- Working telephone
- English Speaking
Exclusion Criteria:
- Current pregnancy or pregnancy in the previous two months
- Breastfeeding with amenorrhea
- Hepatic p450 enzyme inducing medications other than AEDs (griseofulvin, rifampin, St. John's Wort, bosentan)
- Depomedroxyprogesterone acetate within previous six months
- Congenital or acquired uterine anomaly, including myomas, that distort the uterine cavity
- Acute pelvic infection or a history pelvic infection without subsequent intrauterine pregnancy
- Postpartum endometritis or infected abortion in the last three months
- Genital bleeding of unknown etiology
- Untreated lower genital tract infection (cervical or vaginal)
- Acute liver disease or liver tumor, benign or malignant
- HIV infection or partner with HIV infection
- Increased susceptibility to pelvic infection
- A previously inserted intrauterine device (IUD) that has not been removed
- Hypersensitivity to any component of the LNG IUS
- Known or suspected carcinoma of the breast
- 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
- History of genital tract malignancy
- Current use of anti-coagulants
- Current alcoholism or drug abuse

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362373
United States, New York | |
Columbia University | |
New York, New York, United States, 10032 |
Principal Investigator: | Anne Davis, MD | Columbia University |
Responsible Party: | Anne Davis, Associate Professor of Clinical Obstetrics and Gynecology, Columbia University |
ClinicalTrials.gov Identifier: | NCT02362373 History of Changes |
Other Study ID Numbers: |
AAAI0750 |
First Posted: | February 12, 2015 Key Record Dates |
Results First Posted: | January 18, 2016 |
Last Update Posted: | January 18, 2016 |
Last Verified: | December 2015 |
epilepsy contraception drug interaction |
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Levonorgestrel Anticonvulsants |
Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptives, Oral, Synthetic Contraceptives, Oral |