MenopausePhase 2NCT00027209
Hormone Replacement in Menopausal Women With Epilepsy
A Phase 2 study testing prempro in people with Menopause and Epilepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 0 years and older, women only
- What is being tested?
- prempro
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital-Weill Medical College of Cornell University, Comprehensive Epilepsy Center
New York, New York, 10021
About this study
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.
- Being tested
- prempro
- Keywords
- seizures, epilepsy, menopause
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
premproDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 125 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027209
- Sponsor's protocol ID
- R01NS038473
- Status last verified
- Nov 2005
- First submitted
- 28 Nov 2001
- Last updated
- 15 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormone Replacement in Menopausal Women With Epilepsy
- ClinicalTrials.gov ID
- NCT00027209
- Acronym / sponsor ID
- R01NS038473
- Keywords
- seizures, epilepsy, menopause
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- First posted
- 29 Nov 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prempro | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing prempro in people with Menopause and Epilepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2006; AzTrials last refreshed its copy on 26 Oct 2026.