A Clinical Trial Assessing Safety of MF101 for Hot Flushes

• Status: Unknown status
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This Phase 1, open label, randomized clinical trial will enroll 40 generally healthy, postmenopausal women aged 40-65 years old. Women will be randomized to one of two oral doses of MF101 for 4 weeks. Participants will be recruited at 3 clinical sites in the United States.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bionovo

Criteria

Inclusion Criteria (partial list):

• Postmenopausal women aged 40-65 years.

• Provide informed consent.

• Currently receive medical care from a health care provider. Other inclusions apply.

Exclusion Criteria (partial list):

• History of malignancy other than non-melanoma skin cancer or cervical cancer that was diagnosed and fully treated less than 5 years before screening.

• Unexplained uterine bleeding within 6 months prior to Screening.

• History of deep vein thrombosis or pulmonary embolism.

• Active liver disease or a history of impaired.

• Active gallbladder disease. Other exclusions apply.