G Samsioe1, J Hruska. 1. Department of Obstetrics and Gynecology, Kvinnokliniken, Universitetssjukhuset, Lund, Sweden.
Abstract
OBJECTIVE: To evaluate the influence of two ultra-low doses of oral continuous combined hormone therapy and placebo on metabolic parameters, and to assess safety endpoints and overall tolerability in healthy postmenopausal women. DESIGN: In a subpopulation of the Clinical study on Hormone dose Optimisation In Climacteric symptoms Evaluation (CHOICE) trial, lipids and parameters of glucose metabolism and hemostasis were analyzed in Nordic women (n = 158) at baseline and after 12 and 24 weeks of treatment with 0.5 mg 17beta-estradiol (E2) + 0.25 mg norethisterone acetate (NETA), 0.5 mg E2 + 0.1 mg NETA or placebo. Adverse events occurring from the first trial-related activity, whether related or not related to the study medication, were recorded for the entire population (n = 575) of the trial. The seriousness, relationship to treatment and the reason for withdrawal were reported. RESULTS: Both ultra-low-dose combinations were neutral to changes in lipid and lipoprotein, hemostasis parameters and carbohydrate metabolism during the trial. The incidence of serious adverse events was only 1% in respective treatment groups. Adverse events were the reason for withdrawal in only 2% and 6% of women in the 0.5 mg E2 + 0.25 mg and 0.1 mg NETA groups, and in 8% in the placebo group. No weight gain or change in blood pressure was reported during the trial in any of the study groups. CONCLUSION: The treatments had neutral effects on metabolic parameters in the study population. Excellent tolerability of both ultra-low doses resulted in high completion rates.
RCT Entities:
OBJECTIVE: To evaluate the influence of two ultra-low doses of oral continuous combined hormone therapy and placebo on metabolic parameters, and to assess safety endpoints and overall tolerability in healthy postmenopausal women. DESIGN: In a subpopulation of the Clinical study on Hormone dose Optimisation In Climacteric symptoms Evaluation (CHOICE) trial, lipids and parameters of glucose metabolism and hemostasis were analyzed in Nordic women (n = 158) at baseline and after 12 and 24 weeks of treatment with 0.5 mg 17beta-estradiol (E2) + 0.25 mg norethisterone acetate (NETA), 0.5 mg E2 + 0.1 mg NETA or placebo. Adverse events occurring from the first trial-related activity, whether related or not related to the study medication, were recorded for the entire population (n = 575) of the trial. The seriousness, relationship to treatment and the reason for withdrawal were reported. RESULTS: Both ultra-low-dose combinations were neutral to changes in lipid and lipoprotein, hemostasis parameters and carbohydrate metabolism during the trial. The incidence of serious adverse events was only 1% in respective treatment groups. Adverse events were the reason for withdrawal in only 2% and 6% of women in the 0.5 mg E2 + 0.25 mg and 0.1 mg NETA groups, and in 8% in the placebo group. No weight gain or change in blood pressure was reported during the trial in any of the study groups. CONCLUSION: The treatments had neutral effects on metabolic parameters in the study population. Excellent tolerability of both ultra-low doses resulted in high completion rates.
Authors: Carey E Gleason; N Maritza Dowling; Whitney Wharton; JoAnn E Manson; Virginia M Miller; Craig S Atwood; Eliot A Brinton; Marcelle I Cedars; Rogerio A Lobo; George R Merriam; Genevieve Neal-Perry; Nanette F Santoro; Hugh S Taylor; Dennis M Black; Matthew J Budoff; Howard N Hodis; Frederick Naftolin; S Mitchell Harman; Sanjay Asthana Journal: PLoS Med Date: 2015-06-02 Impact factor: 11.069
Authors: Lucia Costa-Paiva; Maria Celeste O Wender; Rogerio B Machado; Luciano M Pompei; Eliana A Nahas; Jorge Nahas-Neto; Sonia Y Del Debbio; Mariangela Badalotti; Achilles M Cruz Journal: Post Reprod Health Date: 2022-08-07