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Trial record 3 of 405 for:    LEVONORGESTREL

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
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Anne Davis, Columbia University

Tracking Information
First Submitted Date  ICMJE February 9, 2015
First Posted Date  ICMJE February 12, 2015
Results First Submitted Date  ICMJE December 14, 2015
Results First Posted Date  ICMJE January 18, 2016
Last Update Posted Date January 18, 2016
Study Start Date  ICMJE August 2011
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2015)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2015)
  • percent change in lamotrigine level [ Time Frame: from baseline to 21 days after LNG IUS insertion ]
    serum trough level of lamotrigine
  • percent change in lamotrigine level [ Time Frame: from baseline to three months after LNG IUS insertion ]
    serum trough level of lamotrigine
  • percent change in lamotrigine level [ Time Frame: from baseline to six months after LNG IUS insertion ]
    serum trough level of lamotrigine
  • percent change in levetiracetam level [ Time Frame: from baseline to 21 days after LNG IUS insertion ]
    serum trough level of levetiracetam
  • percent change in levetiracetam level [ Time Frame: from baseline to 3 months after LNG IUS insertion ]
    serum trough level of levetiracetam
  • percent change in levetiracetam level [ Time Frame: from baseline to 6 months after LNG IUS insertion ]
    serum trough level of levetiracetam
  • percent change in oxcarbazepine level [ Time Frame: from baseline to 21 days after LNG IUS insertion ]
    serum trough level of oxcarbazepine
  • percent change in oxcarbazepine level [ Time Frame: from baseline to 3 months after LNG IUS insertion ]
    serum trough level of oxcarbazepine
  • percent change in oxcarbazepine level [ Time Frame: from baseline to 6 months after LNG IUS insertion ]
    serum trough level of oxcarbazepine
  • Change in seizure frequency: baseline month compared to six month study period [ Time Frame: seven months ]
    Percentage of participants with increased, unchanged or decreased mean monthly seizure frequency
Change History Complete list of historical versions of study NCT02362373 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2015)
continuation [ Time Frame: 6 months ]
percent women continuing the IUD for contraception at 6 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Women With Epilepsy: a Pilot Study of PK and PD Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users
Official Title  ICMJE Women With Epilepsy: a Pilot Study of Pharmacokinetic and Pharmacodynamic Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Epilepsy
  • Contraception
Intervention  ICMJE Drug: levonorgestrel IUS
placement of levonorgestrel intrauterine system
Other Name: Mirena
Study Arms  ICMJE 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.
Intervention: Drug: levonorgestrel IUS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2015)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02362373
Other Study ID Numbers  ICMJE AAAI0750
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anne Davis, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Bayer
Investigators  ICMJE
Principal Investigator: Anne Davis, MD Columbia University
PRS Account Columbia University
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP