Role of Hormones in Susceptibility to Seizures in Women With Epilepsy
Public ClinicalTrials.gov record NCT00044252. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Role of Serum Gonadal and Neuroactive Steroids in the Seizure Susceptibility of Women With Catamenial Epilepsy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will measure and compare hormone levels in women with catamenial epilepsy (epilepsy in which seizures are more frequent during menstrual periods), women with seizures not related to their menstrual cycle, and normal control subjects. It will determine whether there are differences among the three groups in their hormone levels or in how fast the levels change. It will also examine what relationship, if any, exists between hormone changes and seizures in women with catamenial epilepsy. The hormones under study include the gonadal hormones estrone, estradiol and progesterone, and the neuroactive steroids allopregnanolone, pregnenolone, and dehydroepiandrosterone. Women who meet the following criteria may be eligible for this 3-month study: * Between 18 and 45 years of age, with catamenial epilepsy * Between 18 and 45 years of age, with seizures, but not catamenial epilepsy * Between 18 and 45 years of age, without seizures All participants will have a physical examination at the beginning of the study, at each clinic visit, and at completion or withdrawal from the study. In addition, they will undergo the following procedures: Baseline Monitoring For the first 2 months, all participants will keep a diary of their temperature and onset of menses. Women with epilepsy will also record their seizures. Electroencephalography (EEG) Healthy volunteers will have a 45-minute EEG (recording of the electrical activity of the brain) at the beginning of each menstrual cycle and each day during the menses. Women with epilepsy will have continuous EEG monitoring for 8 days, beginning 5 days before their menstrual period is expected. The continuous monitoring can be done on an outpatient basis, using a portable EEG recording device, or as an inpatient, with admission to the hospital for the 8 days of recording. Blood Sampling All participants will have a small blood sample (2 teaspoons) drawn once a day on days 10, 14, 17, 19 and 21 of their menstrual cycle and three times a day on day 6 and for a period of 8 days, starting 5 days before the expected menses and continuing for 3 days of the next cycle. For the days with three blood draws, a small needle that can stay in place for up to 72 hours will be placed in the arm to avoid the discomfort of multiple needle sticks.
Study identification
- NCT ID
- NCT00044252
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 25, 2002
- Primary completion
- Not listed
- Completion
- Jan 21, 2008
- Last update posted
- Jul 1, 2017
2002 – 2008
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00044252, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2017 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00044252 live on ClinicalTrials.gov.