Bionovo will commence dosing in the Phase 3 pivotal clinical trial to assess the safety and efficacy of two doses of Menerba (MF101) to treat menopausal hot flashes postmenopausal women.
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Menerba, an oral, estrogen receptor beta (ER-b) selective drug candidate is developed to treat vasomotor symptoms (hot flashes) associated with menopause, which is manufactured from botanical sources.
The trial will enroll 1,200 postmenopausal women between the ages of 40 and 65 years, who will be randomized to Menerba 5g/day, Menerba 10g/day or placebo and treated for 12 weeks.
The study intends to determine the safety and efficacy of two doses of Menerba compared to placebo after 12 weeks of treatment and efficacy will be measured by the reduction of moderate to severe hot flushes from baseline to 12 weeks of treatment.
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