Hormone Replacement in Menopausal Women With Epilepsy

NCT00027209 | Completed Phase 2

• 1 other identifier: R01NS038473
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause; Epilepsy

Keywords

seizures; epilepsy; menopause

Interventions

prempro DRUG

Eligibility Criteria

• Age: 0 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

New York Presbyterian Hospital-Weill Medical College of Cornell University, Comprehensive Epilepsy Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Prempro

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 28, 2001
• First Posted: November 29, 2001
• Last Updated: May 15, 2006

Record last verified: 2005-11

Locations

US (1)