Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals
Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
Participant gender:
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.