Clinical Study Examining Use of an Over-the-Counter Supplement for the Prevention of Menstrually-… (NCT00203255) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study Examining Use of an Over-the-Counter Supplement for the Prevention of Menstrually-Associated Migraine Headache
United States25 participantsStarted 2003-05
Plain-language summary
The purpose of this trial is to study the use of soy isoflavones in the prevention of menstrually-associated migraines. Additionally, this trial may provide insight into the menstrual cycle and menstrually-related headaches in women. With this information, we may be able to change current treatment methods or even develop new methods in order to advance current approaches in the treatment of menstrual migraine.
Who can participate
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:
•Subjects who have experienced regular menstrual cycles for the past 6 months (every 21 to 35 days) •Subjects who have a history of migraine with or without aura that meets IHS criteria for at least 6 months preceding the study. •Subjects who have headaches associated with menstruation, either pre-menstrually or menstrually (defined as from day -3 through the cessation of menstrual flow) at least 75% of the time (3 out of the past 4 months). •Subjects must experience a menstrually-associated migraine during the baseline month, as defined above. •Subjects must be able to accurately predict onset on menses (within 2 days). This will be confirmed during the baseline month. •Subjects who have been on stable headache preventive medications for the 3 months prior to screening. •Subject has negative urine pregnancy test prior to study entry, and is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential •Subject is able to understand and comply with all study requirements •Subject provides written informed consent prior to any screening procedures being conducted
Exclusion Criteria:
* Subjects who are breastfeeding, pregnant or planning to become pregnant within the next 4 months. •Subjects who are currently on or have been on within three months prior to screening; hormonal contraceptives (oral, injection, or implants), hormone replacement thera…
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.
What they're measuring
1
To compare headache outcome measures between baseline and soy treatment periods. Headache outcome measures include frequency and duration of menstrually-associated migraine (MAM), as well as presence or absence of associated symptoms