A Study to Look at Hormone Levels While on Lamictal or Depakote With or Without an Oral Contraceptive

Verified by: Beth Israel Deaconess Medical Center, March 2010
First Received: February 21, 2006 | Last Updated: March 15, 2010 | Phase: N/A | Start Date: February 2006
Overall Status: Completed | Estimated Enrollment: 48
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Some antiseizure medication levels are affected by hormones. This study is being done to determine if blood levels of lamotrigine or valproate are affected by the hormones in the birth control pill or the menstrual cycle itself...

Brief Summary

Official Title: “Variation of Serum Valproate and Lamotrigine Levels in Relation to The Menstrual Cycle and Oral Contraceptive Use”

Some antiseizure medication levels are affected by hormones. This study is being done to determine if blood levels of lamotrigine or valproate are affected by the hormones in the birth control pill or the menstrual cycle itself.

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: February 2009

Detailed Clinical Trial Description

Participants will be given informed consent and will be asked to have two blood draws at specific times of the menstrual cycle or if on a birth control pill, during the active and inactive pill phases.

Arms, Groups and Cohorts in this Clinical Trial

  • : 1
    • Valproate monotherapy
  • : 2
    • Valproate monotherapy with combined oral contraceptive
  • : 3
    • Lamotrigine monotherapy
  • : 4
    • Lamotrigine monotherapy with combined oral contraceptive

Outcome Measures for this Clinical Trial

Primary Measures

  • To carry out a controlled investigation to determine if combined oral contraceptive (COC) use affects serum valproate (VPA) and lamotrigine (LTG) levels
    • Time Frame: 3 years
      Safety Issue?: Yes
  • To distinguish any apparent COC effects from the potential effects of the naturally occurring high (mid luteal) and low (early follicular, menstrual) steroid phases of the menstrual cycle itself
    • Time Frame: 3 years
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Must be a female between 13-45 years of age
  • Must have a history of seizures
  • Must be taking either lamotrigine (Lamictal) or valproate (Depakote) with or without a birth control pill

Exclusion Criteria:

  • Must not be on antidepressant medication, tranquilizers, or other forms of hormonal therapy other than the birth control pill

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Beth Israel Deaconess Medical Center Other

Overall Clinical Trial Officials and Contacts

Andrew G. Herzog, M.D., M.Sc. Principal Investigator Beth Israel Deaconess Medical Center  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00296413

Study ID Number: 2005-P-000379

ClinicalTrials.gov Identifier: NCT00296413

Health Authority: United States: Institutional Review Board

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