search
Back to results

Hormone Replacement in Menopausal Women With Epilepsy

Primary Purpose

Menopause, Epilepsy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
prempro
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause focused on measuring seizures, epilepsy, menopause

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 28, 2001
Last Updated
May 12, 2006
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00027209
Brief Title
Hormone Replacement in Menopausal Women With Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

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.
Detailed Description
This study will help to answer questions regarding the use of hormone replacement therapy that women with epilepsy face as they reach menopause. The total duration of the study is 6 months and involves 7 visits to the doctor. The purposes of the study are to discover if and how menopause and treatments for the symptoms of menopause change epilepsy in women, to determine which if any factors present before and/or during menopause may predict the influence of menopause on a woman's seizure disorder, and to find any possible interactions between hormone replacement therapy and anti-seizure medication in order to find the optimal dose of hormone replacement therapy for women with epilepsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Epilepsy
Keywords
seizures, epilepsy, menopause

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
125 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
prempro

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
New York Presbyterian Hospital-Weill Medical College of Cornell University, Comprehensive Epilepsy Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Hormone Replacement in Menopausal Women With Epilepsy

We'll reach out to this number within 24 hrs