A Twelve Week Study to Investigate the Efficacy of Femarelle®, for the Treatment of Post Menopausal Vaginal Atrophy

Inclusion Criteria: Healthy post menopausal women between the ages of 40-85+yrs who complain of vaginal dryness with at least three urogenital symptoms from the following: vaginal dryness, vaginal irritation, vaginal soreness, dysuria, dyspareunia, bleeding with coitus \& one of these symptoms must be moderate to severe as determined by patient, Moderate: discomforting and aware of it with activities. Severe: discomforting enough to interfere with activities Activities include sitting, walking, running, urinating, as well as sexual activity * BMI 18-34 (inclusive). * Patients having a LMP at least one year ago, either natural or surgical. * Patients with a normal mammogram within 9 months prior to enrollment. * Patients able to adhere to the visit schedule and protocol requirements and be available to complete the study. * Patients who provide written informed consent to participate in the study. * FSH \> 40 mIU/m. * Estradiol \< 20 pg/ml. * Vaginal PH \> 5. * \< 5% superficial cells as assessed by vaginal cytology. * Normal pelvic and breast exams by investigator. Exclusion Criteria: Patients using HRT (cannot have used for past 3 months). * Patients consuming over the last three months high soy diet or any foods or other compounds that are sold as remedies for the post menopausal symptoms. * Any history of significant cancer or pre-cancer, neurological, renal, cardiovascular, respiratory (e.g. asthma, COPD), hypercoagulability, hematopoietic disease, immune deficiency or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications. * Patients with any clinically significant abnormality upon examination at screening visit. * Patients with a known history of drug or alcohol abuse. * Known hypersensitivity and/or allergy to soy or flax. * Participation in another clinical trial within the past 30 days.