EpilepsyPhase 4WESAILNCT02362373
Women With Epilepsy: a Pilot Study of PK and PD Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users
A Phase 4 study testing levonorgestrel IUS in people with Epilepsy and Contraception, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Epilepsy, Contraception
- What is being tested?
- levonorgestrel IUS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jan 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Epilepsy, Contraception
- Being tested
- levonorgestrel IUS
- Keywords
- epilepsy, contraception, drug interaction
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levonorgestrel IUSDrug
Also called Mirena
placement of levonorgestrel intrauterine system
| Study group | Role | What they receive |
|---|---|---|
| levonorgestrel IUS | Other | all women in the study underwent placement of the levonorgestrel IUS in an open-label fashion, outcomes were compared before and after placement. Receives: Drug: levonorgestrel IUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants That Experienced Clinically Meaningful Change in Lamotrigine Level
The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of lamotrigine after IUD insertion.
Measured: from baseline to 6 months after LNG IUS insertion
Percent of Participants That Experienced Clinically Meaningful Change in Levetiracetam Level
The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of levetiracetam after IUD insertion.
Measured: from baseline to 6 months after LNG IUS insertion
Percent of Participants That Experienced Clinically Meaningful Change in Oxcarbazepine Level
The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of oxcarbazepine after IUD insertion.
Measured: from baseline to 6 months after LNG IUS insertion
Secondary outcomes (2)
Change in Seizure Frequency
Number of participants with increased, unchanged or decreased mean monthly seizure frequency.
Measured: baseline to 6 months
Number of Participants Continuing With IUD
Women continuing the IUD for contraception at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startAug 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Anne Davis, Columbia University
- Investigators
- Anne Davis, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362373
- Sponsor's protocol ID
- AAAI0750
- Acronym
- WESAIL
- Status last verified
- Dec 2015
- First submitted
- 9 Feb 2015
- Last updated
- 18 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Vieira CS, Pack A, Roberts K, Davis AR. A pilot study of levonorgestrel concentrations and bleeding patterns in women with epilepsy using a levonorgestrel IUD and treated with antiepileptic drugs. Contraception. 2019 Apr;99(4):251-255. doi: 10.1016/j.contraception.2018.11.018. Epub 2018 Dec 4.
PubMed 30529085
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women With Epilepsy: a Pilot Study of Pharmacokinetic and Pharmacodynamic Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users
- ClinicalTrials.gov ID
- NCT02362373
- Acronym / sponsor ID
- WESAIL / AAAI0750
- Conditions
- Epilepsy, Contraception
- Keywords
- epilepsy, contraception, drug interaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Aug 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Posted 18 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| levonorgestrel IUS | Other | Drug: levonorgestrel IUSall women in the study underwent placement of the levonorgestrel IUS in an open-label fashion, outcomes were compared before and after placement. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levonorgestrel IUSAlso: Mirenaplacement of levonorgestrel intrauterine system | Drug | levonorgestrel IUS |
Primary outcome
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.
2 secondary outcomes
Change in Seizure Frequency
Time frame: baseline to 6 months
Number of Participants Continuing With IUD
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30529085Vieira CS, Pack A, Roberts K, Davis AR. A pilot study of levonorgestrel concentrations and bleeding patterns in women with epilepsy using a levonorgestrel IUD and treated with antiepileptic drugs. Contraception. 2019 Apr;99(4):251-255. doi: 10.1016/j.contraception.2018.11.018. Epub 2018 Dec 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Davis, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levonorgestrel IUS in people with Epilepsy and Contraception, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants That Experienced Clinically Meaningful Change in Lamotrigine Level (time frame: from baseline to 6 months after LNG IUS insertion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02362373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2016.