A Study of MF101 in Postmenopausal Women

Exclusion Criteria

• •History of malignancy, with the exception of certain types of skin cancer or cervical cancer
• •Known carrier of BRCA1 or BRCA2
• •Abnormal mammogram or breast examination suggestive of cancer within 9 months of screening
• •Endometrial hyperplasia, polyps or abnormal uterine masses (with the exception of fibroids)
• •Clinical evidence of active ischemic heart disease, history of cardiovascular disease, uncontrolled hypertension, or a history of transient ischemic attacks or cerebrovascular accidents
• •History of deep vein thrombosis, pulmonary embolism, severe chronic diarrhea, chronic constipation, uncontrolled inflammatory bowel syndrome or disease (IBS or IBD), or unexplained weight loss
• •Active liver disease or gall bladder disease
• •History of chronic hepatitis B, hepatitis C, hepatitis within 3 months, or HIV infection
• •Use of prescription medications or herbal/dietary supplements for the treatment of hot flushes or those with known estrogenic/progestogenic activity within required wash-out timeframes
• •Use of selective receptor modulators (SERMs), aromatase inhibitors, gonadotropin-releasing hormone agonists, selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin or clonidine within required wash-out timeframes
• •Chronic use of morphine or other opiates