Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
125 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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prempro
Eligibility Criteria
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Inclusion Criteria
* 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 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.
0 Years
FEMALE
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Locations
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New York Presbyterian Hospital-Weill Medical College of Cornell University, Comprehensive Epilepsy Center
New York, New York, United States
Countries
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Other Identifiers
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