title: A Selective Estrogen Receptor Beta Agonist for the Treatment of Hot Flushes: Phase 2 Clinical Trial.
abstract: OBJECTIVE
  The aim of this study was to evaluate the safety, tolerability, and efficacy of a selective estrogen receptor beta (ERβ) 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.
authors.affiliation: 1 Dr. Tagliaferri Formulas, Inc. , San Anselmo, CA.
authors.forename: Mary A
authors.initials: MA
authors.lastname: Tagliaferri
authors.affiliation: 1 Dr. Tagliaferri Formulas, Inc. , San Anselmo, CA.
authors.forename: Margit C
authors.initials: MC
authors.lastname: Tagliaferri
authors.affiliation: 2 Department of Obstetrics and Gynecology, University of California , San Francisco, San Francisco, CA.
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Creasman
authors.affiliation: 3 Medical Center for Clinical Research , San Diego, CA.
authors.forename: William D
authors.initials: WD
authors.lastname: Koltun
mesh_terms: D000328:Adult; D000368:Aged; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D047629:Estrogen Receptor beta / Q000819:agonists*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; D047629:Estrogen Receptor beta