Status:
COMPLETED
A Study to Look at Antiepileptic Drug Levels While on Lamictal or Depakote With or Without an Oral Contraceptive
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Rhode Island Hospital
Conditions:
Epilepsy
Eligibility:
FEMALE
13-45 years
Brief Summary
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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- Must not be on antidepressant medication, tranquilizers, or other forms of hormonal therapy other than the birth control pill
Key Trial Info
Start Date :
February 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00296413
Start Date
February 1 2006
End Date
February 1 2009
Last Update
March 14 2017
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215