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 ß 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.