Clinical Trial Assessing Toxicity and Efficacy of MF101 for Hot Flashes

Exclusion Criteria

• •Inability to sign an informed consent or fill out questionnaires.
• •History of breast, uterine or ovarian cancer or melanoma.
• •Abnormal mammogram or breast examination within the last 9 months suggestive of cancer.
• •Abnormal Pap smear or pelvic examination within the last 9 months suggestive of cancer.
• •Double-wall endometrial thickness that exceeds 5 mm measured on transvaginal ultrasound.
• •Unexplained abnormal uterine bleeding within six months of enrollment.
• •Pregnancy or lactating.
• •Clinical evidence of active ischemic cardiovascular disease or a history of cardiovascular disease.
• •History of deep vein thrombosis or pulmonary embolism requiring anticoagulation.
• •Active liver or gallbladder disease.
• •Use of medications, herbal or dietary supplements known to possibly be effective for the treatment of hot flashes within three months of enrollment for oral or transdermal drugs, or within 6 months of enrollment for implanted or injected drugs.
• •Use of raloxifene or tamoxifen within three months of enrollment.
• •Use of another investigational agent within 3 months of enrollment.
• •History of multiple or severe food or medicine allergies.
• •Any medical or psychiatric condition that, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the trial, including severe illness, plans to move, substance abuse, significant problems, or dementia.