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Hormone Replacement in Menopausal Women With Epilepsy

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ClinicalTrials.gov Identifier: NCT00027209
Recruitment Status : Completed
First Posted : November 29, 2001
Last Update Posted : May 15, 2006
Sponsor:
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Menopause Epilepsy Drug: prempro Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 125 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Menopause

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00027209


Locations
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United States, New York
New York Presbyterian Hospital-Weill Medical College of Cornell University, Comprehensive Epilepsy Center
New York, New York, United States, 10021
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
More Information
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ClinicalTrials.gov Identifier: NCT00027209    
Other Study ID Numbers: R01NS038473 ( U.S. NIH Grant/Contract )
First Posted: November 29, 2001    Key Record Dates
Last Update Posted: May 15, 2006
Last Verified: November 2005
Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
seizures
epilepsy
menopause
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases