Menstrual Bleeding Clinical Trial
Official title:
Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using Continuous Oral Contraceptives.
This study will examine the combined effects of a continuous oral contraceptive (OC) regimen
with supplemental estradiol therapy on headache severity and occurrence in subjects with
documented Menstrually Associated Migraines (MAMs). 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 oral
estradiol 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
estradiol or placebo groups.
The purpose of this research study is to examine the effects of continuous oral
contraceptive pills and oral estradiol 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 examine if taking estradiol around the time of the
period will affect the headache, and how it will be affected.
This study is a prospective trial. A subject's participation will last approximately 32
weeks.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment