A Study to Look at Hormone Levels While on Lamictal or Depakote With or Without an Oral Contraceptive
Information source: Beth Israel Deaconess Medical Center
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Phase: N/A
Status: Recruiting
Sponsored by: Beth Israel Deaconess Medical Center Official(s) and/or principal investigator(s):
Andrew G. Herzog, M.D., M.Sc., Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center
Overall contact:
Andrew G. Herzog, M.D., M.Sc., Phone: 617-667-0264
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.
Clinical Details
Official title: Variation of Serum Valproate and Lamotrigine Levels in Relation to The Menstrual Cycle and Oral Contraceptive Use
Study design: Cohort, Prospective
Primary outcome: To carry out a controlled investigation to determine if combined oral contraceptive (COC) use affects serum valproate (VPA) and lamotrigine (LTG) levelsTo 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
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
Minimum age: 13 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
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 and Contacts
Andrew G. Herzog, M.D., M.Sc., Phone: 617-667-0264
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Andrew G. Herzog, M.D.,M.Sc.
Kristen Fowler, MA, Phone: 617-667-0264, Email: kfowler@bidmc.harvard.edu
Andrew G. Herzog, M.D., M.Sc., Principal Investigator
Additional Information
Starting date: February 2006
Ending date: February 2009
Last updated: August 11, 2008
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