Wyeth has provided the data from a phase 3 clinical study. The results showed that the investigational compound – bazedoxifene/conjugated estrogens (BZA/CE), reduced the frequency and severity of hot flushes and improved measures of vaginal atrophy, when compared to placebo.
BZA/CE is intended for the treatment of moderate-to-severe menopausal vasomotor symptoms such as hot flushes, night sweats and vulvar and vaginal atrophy. It is also meant for the prevention of postmenopausal osteoporosis.
In this study, uterine bleeding was not statistically different from placebo and the rate of endometrial hyperplasia in doses being considered for therapeutic use was <1%, said the company.
Reportedly, SMART-1 was designed to explore the hypothesis that bazedoxifene, when paired with conjugated estrogens, may have the potential to eliminate the need for progestin in menopausal therapy in women with an intact uterus.