Bleeding Clinical Trial
Official title:
Prevention of Menstrual Migraines: Effects of Continuous Oral Contraceptives to Combination With Prophylactic Frovatriptan Use 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 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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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