Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals (MAM)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Prevention of Menstrual Migraines: Effects of Continuous Oral Contraceptives to Combination With Prophylactic Frovatriptan Use During Hormone Free Intervals|
- Comparing baseline menstrually associated migraines (MAMs)to headache occurrence and severity after the implementation of continuous OC therapy. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Compare amount of bleeding and spotting within subjects in relation to duration of extended oral contraceptive pills (OCP) use for those previously using the 21/7 day regimen and those initiating OCP use directly from spontaneous cycling. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Experimental: Group 2
Frovatriptan or placebo given in a certain sequence depending on what group that the woman are randomized to.
Frovatriptan 2.5 mg or placebo given Bid starting on the last day of OC before taking the 4 day HFI. They will take a total of 10 pills max per HFI.
Other Name: frovaDrug: placebo
Group I will receive in a different sequence either frovatriptan 2.5 mg or placebo bid starting the last day of taking OC and continuing during the hormone free interval (HFI) of 4 days.
frovatriptan 2.5 mg bid or placebo starting on the last day of OC and continuing during the 4 day HFI.
Other Name: frovaDrug: placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700128
|United States, Texas|
|Scott & White Memorial Hospital|
|Temple, Texas, United States, 76508|
|Principal Investigator:||Patricia Sulak, MD||Scott and White Hospital|