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
SexFEMALE
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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…
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