R A Lobo1, A M Kaunitz2, N Santoro3, B Bernick4, S Graham4, S Mirkin4. 1. Department of Obstetrics and Gynecology, Columbia University Medical Center , New York , NY , USA. 2. Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville , Jacksonville , FL , USA. 3. Department of Obstetrics and Gynecology, University of Colorado School of Medicine , Aurora , CO , USA. 4. TherapeuticsMD , Boca Raton , FL , USA.
Abstract
Objective: This study aimed to evaluate the effects of TX-001HR (17β-estradiol [E2] and progesterone [P4] in a single oral capsule) on cardiometabolic markers and outcomes. Methods: Four E2/P4 doses (1 mg/100 mg, 0.5 mg/100 mg, 0.5 mg/50 mg, 0.25 mg/50 mg) were compared with placebo in menopausal women with vasomotor symptoms (VMS) and a uterus in the phase 3 REPLENISH (ClinicalTrials.gov, NCT01942668) trial. Changes in lipid and coagulation parameters and blood glucose from baseline at 6, 9, and 12 months as well as cardiovascular events are summarized. Results: A total of 1835 participants took ≥1 capsule of daily E2/P4; 1684 received E2/P4 and 151 receivedplacebo. No clinically significant changes in lipid parameters, coagulation factors, or glucose were observed between treatment groups. Minimal increases of potential clinical importance were observed in total cholesterol, triglycerides, and glucose at month 12 with E2/P4 (1-4%, 6-11%, and 1%, respectively) and placebo (3%, 7%, and 2%, respectively). One episode of deep venous thrombosis and three cases of cardiovascular disease were observed, similar to expected rates of these events in the general population. Conclusions: In the REPLENISH trial, postmenopausal women with VMS treated with E2/P4 had no clinically meaningful effects on lipids, glucose, or coagulation parameters compared with placebo.
RCT Entities:
Objective: This study aimed to evaluate the effects of TX-001HR (17β-estradiol [E2] and progesterone [P4] in a single oral capsule) on cardiometabolic markers and outcomes. Methods: Four E2/P4 doses (1 mg/100 mg, 0.5 mg/100 mg, 0.5 mg/50 mg, 0.25 mg/50 mg) were compared with placebo in menopausal women with vasomotor symptoms (VMS) and a uterus in the phase 3 REPLENISH (ClinicalTrials.gov, NCT01942668) trial. Changes in lipid and coagulation parameters and blood glucose from baseline at 6, 9, and 12 months as well as cardiovascular events are summarized. Results: A total of 1835 participants took ≥1 capsule of daily E2/P4; 1684 received E2/P4 and 151 received placebo. No clinically significant changes in lipid parameters, coagulation factors, or glucose were observed between treatment groups. Minimal increases of potential clinical importance were observed in total cholesterol, triglycerides, and glucose at month 12 with E2/P4 (1-4%, 6-11%, and 1%, respectively) and placebo (3%, 7%, and 2%, respectively). One episode of deep venous thrombosis and three cases of cardiovascular disease were observed, similar to expected rates of these events in the general population. Conclusions: In the REPLENISH trial, postmenopausal women with VMS treated with E2/P4 had no clinically meaningful effects on lipids, glucose, or coagulation parameters compared with placebo.
Authors: Benson M Hamooya; Patrick Musonda; Wilbroad Mutale; Sepiso K Masenga; Hikabasa Halwiindi; Katongo H Mutengo; Kaseya O R Chiyeñu; Gershom Chongwe; John R Koethe; Loren Lipworth; Douglas C Heimburger Journal: PLoS One Date: 2021-02-16 Impact factor: 3.240
Authors: Andrew M Kaunitz; Diana Bitner; Ginger D Constantine; Brian Bernick; Shelli Graham; Sebastian Mirkin Journal: Menopause Date: 2020-12 Impact factor: 3.310
Authors: James H Liu; Denise R Black; Lisa Larkin; Shelli Graham; Brian Bernick; Sebastian Mirkin Journal: Menopause Date: 2020-12 Impact factor: 3.310