Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment) Of Menstrual Migraine (NCT00904098) | Clinical Trial Compass
CompletedPhase 4
Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment) Of Menstrual Migraine
United States192 participantsStarted 2005-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Had MM headaches occurring between Day -2 and Day +3 of menses
. Had at least one year history of MM headaches
. Had at least 8 MM headaches in the previous 12 menstrual cycles (1 year)
. Had regular predictable menstrual periods (28 ± 4 days)
Exclusion criteria
. Had a history of more than 15 headache days per month
. As part of current MM treatment, used intermittent prevention with an analgesic (e.g., naproxen for 5 days to prevent the onset of MM)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. Had significant cerebrovascular disease, including basilar or hemiplegic migraine
. Had uncontrolled hypertension: systolic blood pressure \>180mmHg and diastolic blood pressure \>95mmHg
. Had severe hepatic or renal insufficiency
. Used an analgesic medication (including both prescription and over-the-counter) for any reason \>50% of days per month