A Selective Estrogen Receptor Beta Agonist for the Treatment of Hot Flushes: Phase 2 Clinical Trial

作者：Tagliaferri Mary A; Tagliaferri Margit C; Creasman Jennifer M; Koltun William D

来源：Journal of Alternative and Complementary Medicine, 2016, 22(9): 722-728.

DOI：10.1089/acm.2015.0021

Objective: The aim of this study was to evaluate the safety, tolerability, and efficacy of a selective estrogen receptor beta (ERb) agonist, Dr. Tagliaferri's Menopause Formula (MF102), to treat the symptoms of menopause.
Methods: An open-label trial of MF102 taken for 12 weeks by 30 postmenopausal women aged 40-65 years, who experienced a minimum of five moderate to severe hot flushes per day. The primary efficacy outcome was a change in the frequency of moderate to severe hot flushes from baseline to week 12. A change in the frequency of hot flushes that woke participants from their sleep from baseline to 12 weeks was a secondary endpoint. Lipid profile and endometrial thickness were also evaluated.
Results: Thirty postmenopausal women with an average of nine moderate to severe hot flushes per day were treated with MF102 4 g/day; 27 participants completed the study. The median percent reduction in moderate to severe hot flushes was 71% (p < 0.001). The median percent reduction in hot flushes that woke participants from their sleep was 54% (p < 0.001). Low-density lipoprotein (LDL-C) and total cholesterol both declined significantly from baseline. There were no serious adverse events, reports of abnormal uterine bleeding, or significant changes in double-wall endometrial thickness.
Conclusions: Treatment with MF102 resulted in a marked decrease in the frequency of moderate to severe hot flushes, was well-tolerated, and demonstrated no safety concerns.

• 出版日期2016-9