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| Name | Class |
|---|---|
| Rhode Island Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Valproate monotherapy | ||
| 2 | Valproate monotherapy with combined oral contraceptive | ||
| 3 | Lamotrigine monotherapy | ||
| 4 | Lamotrigine monotherapy with combined oral contraceptive |
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| Measure | Description | Time Frame |
|---|---|---|
| To carry out a controlled investigation to determine if combined oral contraceptive (COC) use affects serum valproate (VPA) and lamotrigine (LTG) levels | 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 | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Two regional epilepsy centers
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| Name | Affiliation | Role |
|---|---|---|
| Andrew G. Herzog, M.D., M.Sc. | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Serum Samples for hormone testing