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CompletedNCT00027209Updated May 15, 2006

Hormone Replacement in Menopausal Women With Epilepsy

A Phase 2 interventional study of prempro in Menopause and Epilepsy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Completed at 1 site in United States. Open to female participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2006-05-15.

Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
125
Allocation
Randomized
Ages
0 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Menopause
  • Epilepsy

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Keywords

  • seizures
  • epilepsy
  • menopause
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 125 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 592 studies on the registry; 56 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Masking
Double
Enrollment
125 participants

Interventions

  • Drugprempro
06

Study locations

1 site
  • New York Presbyterian Hospital-Weill Medical College of Cornell University, Comprehensive Epilepsy Center
    New York, New York 10021, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00027209
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
First posted
Nov 29, 2001
Last update
May 15, 2006
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2005. You cannot join it, but the record below documents what was studied.

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