 - 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 