Status:
COMPLETED
Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals
Lead Sponsor:
Scott and White Hospital & Clinic
Collaborating Sponsors:
Endo Pharmaceuticals
Conditions:
Migraines
Bleeding
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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 Mens...
Eligibility Criteria
Inclusion
- Woman may be on birth control pill (OC), patch or NuvaringTM (vaginal ring) taken in the traditional 21/7 or 24/4 manner, which means ever month they have a period. If they are taking it continuously (without a period), you must be willing to take your birth control 24/4 (4 days taking hormone free interval, HFI) for 2 months.
- If you are not on OCs, patch or NuvaringTM you must have a period every 21-40 days.
- You must not want to get pregnant for 12 months.
- Women have headaches around the time of their period.
Exclusion
- BMI \> 38
- If you smoke and are age 35 years old or greater or if are under 35 years old and smoke over 10 cigarettes a day
- If you have or had an aura with your headaches (An aura is a temporary sensation, like bright lights that come before you experience the headache.)
- Headaches are not occurring during the time of your period.
- Blood Pressure \> 140/90 or you take more than a single antihypertensive medication (excluding diuretics) and are age 40 or greater.
- Contraindications to combination estrogen/progestin hormonal contraception.
- Desire to become pregnant in the next 12 months.
- Refuse to avoid any ergot-based medication, triptan medication or isometheptene/midrin during their hormone free interval or the one day before the hormone free interval
- Stroke
- Breast Cancer
- Blood clots in your legs, lung or anywhere else in your body
- Diabetes mellitus
- Heart attack
- Liver disease
- Lupus Erythematosus
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00700128
Start Date
June 1 2008
End Date
January 1 2010
Last Update
July 25 2011
Active Locations (1)
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1
Scott & White Memorial Hospital
Temple, Texas, United States, 76508