Hormone Replacement in Menopausal Women With Epilepsy

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The goal of this study is to evaluate the effect of synthetic hormone replacement therapy on anti-seizure medication levels, menopausal symptom relief, and seizure frequency and safety in menopausal women with epilepsy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

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.