Hormone Replacement in Menopausal Women With Epilepsy
Menopause, Epilepsy
About this trial
This is an interventional treatment trial for Menopause focused on measuring seizures, epilepsy, menopause
Eligibility Criteria
Inclusion Criteria: Subjects must have a diagnosis of partial epilepsy which has predated the onset of menopause. Subjects must have between 0-10 seizures of any type per month. Subjects must have had an EEG consistent with a partial epilepsy diagnosis, showing a focal abnormality. Subjects must have had an imaging study of the brain since the diagnosis of epilepsy. Subjects must be 1 year menopausal (without their menstrual periods), but within 5 years of their last menstrual period. Subjects must be medically cleared by their primary care physician to take HRT. Subjects must have had a normal PAP smear within the past 9 months. Subjects must have had a mammogram without lesions suspicious for malignancy within the past 9 months. Subjects or their caregivers must be able to keep an accurate seizure diary. Subjects must be stable on their current AEDs for >1 month. Subjects must have not used HRT during the 3 months prior to enrollment. Exclusion Criteria: Subjects with a history of breast, uterine or ovarian cancer. Subjects with a treatable or reversible cause of recurrent seizures (metabolic, neoplastic, toxic or infectious causes). Subjects with a history of deep vein thrombosis, arterial thrombosis, pulmonary embolus, blood clotting disorders, or stroke. Subjects with elevated liver function test more than two time normal. Subjects with 3 first degree family members who have a history of breast cancer. Subjects with 1 first degree family member with a history of bilateral breast cancer. Subjects with a history of complicated migraine headaches. Subjects with a history of unexplained vaginal bleeding. Subjects with a history of familial hyperlipoproteinemia. Subjects with a history of myocardial infarction in the past 6 months. Subjects with diabetes mellitus with vascular disease. Subjects with untreated hypertension (>145/95 on 3 occasions). Subjects with a history of using an experimental drug or device in the past 30 days. Subjects with severe chronic and/or progressive medical illnesses. Subjects with active drug and alcohol abuse. Subjects with a history of discontinuation of Prempro in the past due to side effects. Subjects who state that they cannot tolerate 6 more months without relief of menopausal symptoms. Subjects who plan to change or anticipate a change in their antiseizure treatment in the next 6 months.
Sites / Locations
- New York Presbyterian Hospital-Weill Medical College of Cornell University, Comprehensive Epilepsy Center