Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT00644033
Eligibility Criteria:
Inclusion Criteria:
* Females aged 18 years and over
* 12 month or more documented history of menstrual migraine headache, according to International Headache Society classification
* An average frequency of MAM attacks in at lease 3 out of 4 menstrual cycles
* Regular predictable menstrual periods
* Able to accurately predict the onset of MAM headaches occurring between Day -2 and Day +4 of menses
* Able and willing to sign informed consent to comply with study procedures, including completion of diary cards
Exclusion Criteria:
* More than three migraine attacks per month that were not MAM attacks
* Coronary artery disease including coronary vasospasm
* Significant cerebrovascular disease including basilar or hemiplegic migraine
* Uncontrolled hypertension
* Severe hepatic or renal insufficiency
* More than 15 headache days per month
* Any other condition or serious illness which would interfere with optimal participation in the study
* History of clinically relevant allergy, including that to frovatriptan or other triptans
* Pregnant or breast feeding or intending to become pregnant or to breast-feed during study period
* Participated in other frovatriptan menstrual migraine prevention studies
* Use of another investigation drug within 30 days or 5 half-lives (whichever is longer) before the screening visit
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00644033
Study Brief:
Protocol Section:
NCT00644033