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NCT00700128 · ClinicalTrials.gov registry record · NA
Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals
A NA study, sponsored by Scott and White Hospital & Clinic.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT00700128 is a NA study that has completed, run by Scott and White Hospital & Clinic. The registered enrollment target is 30 participants.
The verdict
NCT00700128, a NA study, has completed, sponsored by Scott and White Hospital & Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will examine the combined effects of a continuous oral contraceptive (OC) regimen with supplemental frovatriptan therapy on headache severity and occurrence in subjects with documented Menstrually Associated Migraines (MAM). The subjects enrolling in the study will have cyclic menses either due to spontaneous ovulation or use of cyclic hormonal contraception (pill, patch, or ring). Enrolled subjects will start a continuous OC regimen following two baseline menstrual cycles. If breakthrough bleeding/spotting (BTB/BTS) occurs, the subject will institute a 4-day hormone-free interval (HFI). In an attempt to prevent/lessen the severity of headache during the HFI, subjects will be randomized to prophylactic administration of a triptan or placebo during this period. If no BTB/BTS occurs after 80 days of continuous pills, the subject will institute a 4-day HFI during which they will be randomized into triptan or placebo groups. The purpose of this research study is to examine the effects of continuous oral contraceptive pills and frovatriptan on headaches that occur around the time of your period. Many woman take continuous oral contraceptive pills (OC) and when OCs are stopped they may get headaches. This study will look if taking frovatriptan around the time of the period will affect the headache, and how it will be affected. Frovatriptan is an FDA approved drug for migraine headaches. This study is a prospective pilot trial.The study will last approximately 35-39 weeks.
Interventions
- DRUG placebo
- DRUG frovatriptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-06 |
| Est. Completion | 2010-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00700128
The ClinicalTrials.gov registry entry for NCT00700128 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Scott and White Hospital & Clinic, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00700128 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00700128 about?
NCT00700128 is a clinical study titled "Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals". This study will examine the combined effects of a continuous oral contraceptive (OC) regimen with supplemental frovatriptan therapy on headache severity and occurrence in subjects with documented Menstrually Associated Migraines (MAM). The subjects enrolling in the study will have cyclic menses eith...
What is the current status of trial NCT00700128?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2008-06. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00700128?
The interventions under investigation include: placebo (DRUG), frovatriptan (DRUG).
Who is sponsoring clinical trial NCT00700128?
This trial is sponsored by Scott and White Hospital & Clinic, which has 9 total clinical trials registered on ClinicalTrials.gov.
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