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Sponsors and Collaborators: |
Beth Israel Deaconess Medical Center Rhode Island Hospital |
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Information provided by: | Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00296413 |
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.
Condition |
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Epilepsy |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Variation of Serum Valproate and Lamotrigine Levels in Relation to The Menstrual Cycle and Oral Contraceptive Use |
Serum Samples for hormone testing
Estimated Enrollment: | 48 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Valproate monotherapy
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2
Valproate monotherapy with combined oral contraceptive
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3
Lamotrigine monotherapy
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4
Lamotrigine monotherapy with combined oral contraceptive
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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.
Ages Eligible for Study: | 13 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Two regional epilepsy centers
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrew G. Herzog, M.D., M.Sc. | 617-667-0264 | |
Contact: Kristen Fowler, MA | 617-667-0264 | kfowler@bidmc.harvard.edu |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Andrew G. Herzog, M.D.,M.Sc. | |
Contact: Kristen Fowler, MA 617-667-0264 kfowler@bidmc.harvard.edu | |
Principal Investigator: Andrew G. Herzog, M.D., M.Sc. |
Principal Investigator: | Andrew G. Herzog, M.D., M.Sc. | Beth Israel Deaconess Medical Center |
Responsible Party: | Beth Israel Deaconess Medical Center ( Andrew G. Herzog, MD ) |
Study ID Numbers: | 2005-P-000379 |
Study First Received: | February 21, 2006 |
Last Updated: | August 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00296413 |
Health Authority: | United States: Institutional Review Board |
epilepsy menstrual cycle valproate lamotrigine oral contraceptive |
Epilepsy Lamotrigine Central Nervous System Diseases Brain Diseases Valproic Acid |
Nervous System Diseases |