Clinical Study Examining Use of an Over-the-Counter Supplement for the Prevention of Menstrually-Associated Migraine Headache
Clinical Study Examining Use of an Over-the-Counter Supplement for the Prevention of Menstrually-Associated Migraine Headache
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.
Many women have increased headache attacks at the time of their period (menses). The
 migraines experienced around the menstrual cycle are most often associated with premenstrual
 complaints such as nausea, backache and breast tenderness. The condition of hormone-related
 headache (i.e. menstrual migraine) is unclear.

 Soy isoflavones have been used to alleviate the symptoms of menopause. They contain natural
 estrogens (female hormones). Since menstrual migraine is thought to be associated with the
 withdrawal of estrogen, or the natural fall of estrogen levels, the use of this natural
 source of estrogen may be helpful in the prevention of menstrually-associated migraine.
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 therapy or any other hormone therapy including natural supplements.
 •Subjects who, in the investigators opinion, have a history or have evidence of a
 medical or psychiatric condition that would expose them to an increased risk of a
 significant adverse event or would interfere with the assessments of efficacy and
 tolerability during this trial •Subjects who experience greater than 15 headache days
 per month •Subjects who have an allergy to soy or soy based products. •Subjects with a
 history of significant drug or alcohol abuse within the past year

 -  Subjects who have participated in an investigational drug trial in the 30 days prior
 to the screening visit •Subjects who have breast cancer or who have a history of
 breast cancer.