Variation of Serum Valproate and Lamotrigine Levels in Relation to The Menstrual Cycle and Oral Contraceptive Use
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- To carry out a controlled investigation to determine if combined oral contraceptive (COC) use affects serum valproate (VPA) and lamotrigine (LTG) levels
Study Overview
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 the menstrual cycle itself.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 13 Years to 45 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Andrew Herzog
Professor of Neurology
Beth Israel Deaconess Medical Center