Mary A Tagliaferri1, Margit C Tagliaferri1, Jennifer M Creasman2, William D Koltun3. 1. 1 Dr. Tagliaferri Formulas, Inc. , San Anselmo, CA. 2. 2 Department of Obstetrics and Gynecology, University of California , San Francisco, San Francisco, CA. 3. 3 Medical Center for Clinical Research , San Diego, CA.
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.
RCT Entities:
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: Brian J Doyle; Temitope O Lawal; Tracie D Locklear; Lorraina Hernandez; Alice L Perez; Udeshi Patel; Shitalben Patel; Gail B Mahady Journal: Pharm Biol Date: 2018-12 Impact factor: 3.503
Authors: Karen K L Chan; Michelle K Y Siu; Yu-Xin Jiang; Jing-Jing Wang; Thomas H Y Leung; Hextan Y S Ngan Journal: Cancer Cell Int Date: 2018-05-01 Impact factor: 5.722