MF101, a selective estrogen receptor β modulator for the treatment of menopausal hot flushes: A phase II clinical trial

Deborah Grady, George F. Sawaya, Karen C. Johnson, William Koltun, Rachel Hess, Eric Vittinghoff, Margaret Kristof, Mary Tagliaferri, Isaac Cohen, Kristine E Ensrud

Research output: Contribution to journalArticlepeer-review

48 Scopus citations

Abstract

OBJECTIVE: To determine the optimal dose, safety, and efficacy of an estrogen receptor β selective Chinese herbal extract, menopausal formula 101 (MF101), for treating hot flushes. METHODS: A randomized, blinded trial in 217 postmenopausal women with hot flushes randomized to 5 or 10 g/day of MF101 or placebo for 12 weeks. RESULTS: The effects of 5 g/day of MF101 did not differ from those of placebo. After 12 weeks, the mean percent decrease in frequency of hot flushes in the 10 g/day group was 12.9% greater than that in the placebo group (P = 0.15), the median percent decrease was 11.7% greater than that in the placebo group (P = 0.05), and the proportion of women with at least a 50% reduction in hot flushes was 16.2% greater than that in the placebo group (P = 0.03). CONCLUSIONS: Treatment with 10 g/day of MF101 reduces the frequency of hot flushes. Trials with higher doses are planned.

Original languageEnglish (US)
Pages (from-to)458-465
Number of pages8
JournalMenopause
Volume16
Issue number3
DOIs
StatePublished - May 1 2009

Keywords

  • Estrogen receptor β selective estrogen
  • Hot flush

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