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:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT00904150
Eligibility Criteria:
Inclusion Criteria:
All cases and controls must:
* Be over 18 years
* Caucasian
* Provide written, informed consent
* Clearly understand and be able to comply with all the trial procedures, as required
* Not have taken part in trials of any investigational products within the previous 4 weeks
DNA Study:
* Cases must have at least a 12-month current or past history of menstrual migraine
RNA Study:
* Cases must have at least a 12-month current history of menstrual migraine
* Cases must have kept at least three months of headache diary data in advance of visit in order to confirm diagnosis
* Controls must still be having menstrual periods
Exclusion Criteria:
DNA Study:
* Cases and controls must not have smoked, chewed gum or consumed any food or drink in the 30 minutes prior to sample collection
RNA Study:
* Cases and controls will not be eligible for participation if they have:
* Polycystic ovarian syndrome;
* Taken any hormones or drugs in the previous three months that may affect normal hormone activity (e.g., hormonal contraceptives, hormone replacement therapy, dietary supplements such as isoflavones);
* Donated or lost a significant amount of blood (\> 550 mL) within the previous 12 weeks
* Additionally, controls must not have a personal or family history in any first-degree relative of current or past migraine
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00904150
Study Brief:
Protocol Section:
NCT00904150