A Double-Blind Study to Evaluate the Effect of Femarelle® on Menopausal on Vasomotor Symptoms

Inclusion Criteria: 1. postmenopausal women, i.e 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/ 2. More than 7 hot flushes per day or over 50 per week at baseline. 3. Women should have documentation of a negative screening mammogram (obtained at screening or within 1 year of study enrolment. 4. Normal pelvic and breast exams by investigator prior to enrolment. 5. All subjects who have a uterus should have endometrial thickness of less than 5mm in vaginal sonogram exam at randomization. 6. Informed consent to participate in the study. Exclusion Criteria: 1. Use of any medication or supplements for menopausal symptoms, such as estrogen/progestin containing drug products, Isoflavons, phytoestrogens and SERM within a minimum of 8 weeks prior to pre-study screening period. 2. Use of SSRIs, St. John's Wort, within a minimum of 8 weeks prior to pre-study screening period. 3. Any clinically unstable or uncontrolled renal, hepatic, endocrine, respiratory, hematological, neurological, cardiovascular or cerebrovascular disease that would put the subject at safety risk or mask measure of efficacy 4. Evidence or history of vascular disease (such as ischemic heart disease), Cerebrovascular accident (such as stroke or transient ischemic attack) or deep vein thrombosis (blood clots), or thromboembolic disorders. 5. Personal history of breast cancer 6. Abnormal clinically relevant vaginal bleeding 7. Any clinically relevant (opinion of investigator) abnormal finding during physical, gynecological and breast examination at screening 8. Abnormal, clinically significant results of mammography 9. Malignancy with the exception of BCC of the skin 10. Known hypersensitivity to gluten, soybeans, soy protein, estrogens and/or progestins 11. History of severe recurrent depression, or severe psychiatric disturbance. Untreated or uncontrolled high blood pressure (hypertension) 12. Participation in a clinical trial within 30 days prior to screening Known substance abuse (alcohol or drug) 13. Unable to comply with study protocol