Safety and Tolerability of Frovatriptan to Prevention of Menstrually Associated Migraine (MAM) Headaches

Inclusion Criteria: * Female aged 15 years and over (≥18 years in United Kingdom and South Africa), with at least a 12 month documented history of experiencing migraine according to IHS criteria, including confirmation of a 3 month diary based documented history of MAM. * An average frequency of MAM in at least two out of three menstrual cycles, within the previous 12 months * Regular, predictable menstrual periods * MAM headaches occurring between Day -2 and day +4 of menses * Able and willing to sign informed consent and to comply with study procedures, including completion of the diary cards. Exclusion Criteria: * More than three migraine attacks per month that were not MAM attacks * A history of myocardial infarction, ischemic heart disease (or presenting with symptoms or signs compatible with ischemic heart disease), coronary vasospasm or peripheral vascular disease * Significant cerebrovascular disease including basilar or hemiplegic migraine * Uncontrolled hypertension (SBP \>180 mmHg, DBP \>95 mmHg) * Severe hepatic or renal insufficiency * More than 15 headache days per month, exclusive of migraine headache * Any other condition or serious illness which, in the opinion of the investigator, would interfere with optimal participation in the study * A history of clinically relevant allergy, including that to frovatriptan or other triptans * Pregnant or breast-feeding, or intending to become pregnant or breast-feed during the study period (patients were to be using ad…