The clinical trial will take place at four academic centers – University of California, the University of Minnesota, the University of Tennessee, and the University of Alabama.
“Recent randomized trials have documented that there are important harms associated with use of postmenopausal hormone therapy. Given this, there is a large unmet need for novel therapies that are both safe and effective for treating menopausal symptoms,” said Dr Deborah Grady, vice chair of the department of epidemiology, and director of the University of California.
Laboratory data shows that Menopause Formula 101 (MF101) does not stimulate estrogen dependent tumor formation or uterine proliferation and therefore may prove to be a safer alternative to the currently available hormone therapies.
In 2002, the Women’s Health Initiative estrogen plus progestin trial with over 16,000 women was stopped early because the standard dose of combination hormone therapy increased the risk of breast cancer, stroke, heart attacks, blood clots and dementia.
“Given the huge market for a safe and effective treatment for menopausal symptoms, we are excited to launch our phase II study of our promising selective estrogen receptor modulator drug candidate,” said Isaac Cohen, Bionovo’s president and CEO.