A Study of MF101 in Postmenopausal Women

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This phase 3a study is designed to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bionovo

Criteria

Inclusion Criteria (limited):

• Confirmed postmenopausal women aged 40-65

• Provide written informed consent

Exclusion Criteria (limited):

• 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