Phase III study of Menerba (Bionovo Inc)commences for Menopausal Hot Flashes

The first patient will begin dosing in the Phase III clinical trial evaluating the safety and efficacy of two doses of the oestrogen receptor beta agonist Menerba (MF101), from Bionovo Inc, among a cohort of postmenopausal women for the treatment of Menopausal Hot Flashes. A total of 50 sites will enroll 1,200 postmenopausal women between the ages of 40 and 65 years. Participants will be randomized to Menerba 5g/day, Menerba 10g/day or placebo and treated for 12 weeks. The primary aims are to determine the safety and efficacy of two doses of Menerba compared to placebo after 12 weeks of treatment which will be measured by the reduction of moderate to severe hot flushes from baseline to 12 weeks of treatment. Principal investigator is Wulf Utian, Executive Director Emeritus and Honorary Founding President of the North America Menopause Society and Professor Emeritus at Case Western Reserve University.