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...
Date First Received: February 21, 2006
Last Updated: August 11, 2008
Verified by: Beth Israel Deaconess Medical Center, January 2008
Clinical Trial Phase: N/A | Start Date: February 2006
Overall Status: Recruiting
Estimated Enrollment: 48
Brief Summary
Official Title: “Variation of Serum Valproate and Lamotrigine Levels in Relation to The Menstrual Cycle and Oral Contraceptive Use”
Condition Keyword(s):
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: Cohort, 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
- 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
Safety Issue?: Yes
- Time Frame: 3 years
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 Sponsor Information
Lead Sponsor: Beth Israel Deaconess Medical Center
Overall Clinical Trial Officials and Contacts
Andrew G. Herzog, M.D., M.Sc. Principal Investigator Beth Israel Deaconess Medical Center
Overall Contact: Andrew G. Herzog, M.D., M.Sc. 617-667-0264
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
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
Clinical Trials Authorship and Review
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