Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment) Of Menstrual Migraine

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Females 18 years of age or older with at least one year history of menstrual migraine (MM) headaches participated in a Phase 4 clinical trial to evaluate the efficacy of frovatriptan when used at the early stage (International Headache Society [IHS] Grade 1) of MM compared with patients' current treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endo Pharmaceuticals
• Treatments: Frovatriptan

Criteria

Inclusion Criteria:

1. Had MM headaches occurring between Day -2 and Day +3 of menses

2. Had at least one year history of MM headaches

3. Had at least 8 MM headaches in the previous 12 menstrual cycles (1 year)

4. Had regular predictable menstrual periods (28 ± 4 days)

Exclusion Criteria:

1. Had a history of more than 15 headache days per month

2. As part of current MM treatment, used intermittent prevention with an analgesic (e.g., naproxen for 5 days to prevent the onset of MM)

3. Had a history of myocardial infarction, ischemic heart disease (or presented with symptoms or signs compatible with ischemic heart disease), coronary vasospasm (including Prinzmetal's variant angina), other significant underlying cardiovascular disease, or peripheral vascular disease

4. Had significant cerebrovascular disease, including basilar or hemiplegic migraine

5. Had uncontrolled hypertension: systolic blood pressure >180mmHg and diastolic blood pressure >95mmHg

6. Had severe hepatic or renal insufficiency

7. Used an analgesic medication (including both prescription and over-the-counter) for any reason >50% of days per month