Study Summary:
This is a research study to determine the effectiveness of an experimental birth control pill for treating menstrually-related migraine headaches. During this study we will compare the experimental drug to placebo. The study drug being studied contains two different hormones, levonorgestrel and ethinyl estradiol taken as a combination pill for 84 days, followed by 7 days of pills containing just one hormone. These hormones are similar to the two naturally occurring hormones made by the ovaries, estrogen and progestin.Although the experimental drug is a birth control pill, the purpose of this study is not to prevent pregnancy.
Study duration will be approximately 20 weeks.
Qualified Participants Must:
• Be a female 18-34 years of age
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Be premenopausal, non-pregnant, and nonlactating
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Weigh less than 200 lbs
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Have a history of migraines without aura for at least 6 months prior to the screening visit
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Have a history of migraines associated with menstruation, either pre-menstrually or menstrually
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Have regular menstrual cycles that occur every 23-33 days for the last 6 months
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If currently using headache preventive medications, must be on a stable dose for at least 2 months prior to the screening visit with no anticipated changes
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Woman at risk must agree to use an effective method of non-hormonal contraception (Non-hormone releasing IUD, diaphragm, spermicidal foam, contraceptive sponge, condoms) throughout the study and extending through 14 days following the last dose
Qualified Participants May Receive:
$50.00 per visit to cover travel, parking, inconvenience, and time away from work or home.