Clinically meaningful efficacy of a non-estrogen agent: re-analysis of phase-2 data evaluating MF101

Abstract

Objective To evaluate the level of reduction in hot flushes among a cohort of postmenopausal women randomized to a phase-2 clinical trial evaluating MF101, a selective estrogen receptor β modulator, for treatment of vasomotor symptoms to determine clinically meaningful efficacy.

Methods We performed a re-analysis of data from a double-blinded, placebo-controlled trial of 217 postmenopausal women randomized to treatment with MF101 or placebo for 12 weeks. At study termination, participants were asked if they were satisfied enough with medication to continue therapy.

Results Of the women treated, 73% with ≥50% reduction in hot flush frequency and 77% with ≥60% reduction in hot flush frequency were willing to continue treatment.

Conclusion: A 50–60% reduction in hot flushes is clinically meaningful among postmenopausal women who are being treated with a non-estrogen agent such as MF101.

Key words::

• HORMONE THERAPY
• HOT FLUSH
• MENOPAUSE
• VASOMOTOR SYMPTOM
• MF101

ACKNOWLEDGEMENT

Permission for reproduction of published material is granted.

Conflict of interest The following individuals are or were employees of Bionovo, Inc.: Mary Tagliaferri, President and Chief Medical Officer; Katie A. Caygill, Previous Director of Clinical Development; Azin Olyaie, Previous Director of Clinical Operations; Isaac Cohen, CEO and Chairman.

Source of funding The study was funded by Bionovo, Inc.