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

Beth Israel Deaconess Medical Center48 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Epilepsy

Eligibility

Sex: FEMALEMin age: 13 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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