OBJECTIVES: The aim of this study was to demonstrate that the therapeutic efficacy of an estradiol 1mg/drospirenone2mg (E2/DRSP) preparation is superior to a placebo in postmenopausal Korean women with hot flushes and other climacteric symptoms, and to demonstrate that this treatment is both safe and tolerable. METHODS: This was a double-blind, randomized, placebo-controlled, multicenter study over four 28-day treatment cycles. A total of 158 subjects were screened and 90 women were randomized into two treatment groups (E2/DRSP group, n=45; placebo group, n=45). The primary efficacy parameter was the individual relative change of hot flushes. The secondary efficacy parameters such as other climacteric, urogenital symptoms and vaginal bleeding patterns were also evaluated, and the occurrence of any adverse events was noted. In addition, physical, gynecological examinations and laboratory analyses were performed at the beginning and end of the study. RESULTS: The mean number of hot flushes per week during treatment weeks 3-16 decreased by 48.1% during treatment with placebo, and by 84.4% during treatment with E2/DRSP (p<0.001). The E2/DRSP combination also reduced the incidence and intensity of menopausal symptoms in postmenopausal women. Most of adverse events was mild or moderate degree of intensity. None of the parameters measured in the study, including laboratory analyses, physical and gynecological examinations, vital signs, and weight, led to any concerns of safety. CONCLUSIONS: The E2 1mg/DRSP 2mg combination tested in the study was efficacious and safe in the treatment of hot flushes and other climacteric symptoms in postmenopausal Korean women.
RCT Entities:
OBJECTIVES: The aim of this study was to demonstrate that the therapeutic efficacy of an estradiol 1mg/drospirenone 2mg (E2/DRSP) preparation is superior to a placebo in postmenopausal Korean women with hot flushes and other climacteric symptoms, and to demonstrate that this treatment is both safe and tolerable. METHODS: This was a double-blind, randomized, placebo-controlled, multicenter study over four 28-day treatment cycles. A total of 158 subjects were screened and 90 women were randomized into two treatment groups (E2/DRSP group, n=45; placebo group, n=45). The primary efficacy parameter was the individual relative change of hot flushes. The secondary efficacy parameters such as other climacteric, urogenital symptoms and vaginal bleeding patterns were also evaluated, and the occurrence of any adverse events was noted. In addition, physical, gynecological examinations and laboratory analyses were performed at the beginning and end of the study. RESULTS: The mean number of hot flushes per week during treatment weeks 3-16 decreased by 48.1% during treatment with placebo, and by 84.4% during treatment with E2/DRSP (p<0.001). The E2/DRSP combination also reduced the incidence and intensity of menopausal symptoms in postmenopausal women. Most of adverse events was mild or moderate degree of intensity. None of the parameters measured in the study, including laboratory analyses, physical and gynecological examinations, vital signs, and weight, led to any concerns of safety. CONCLUSIONS: The E2 1mg/DRSP 2mg combination tested in the study was efficacious and safe in the treatment of hot flushes and other climacteric symptoms in postmenopausal Korean women.
Authors: Bo Ra Park; Hye Na Park; Ji Back Jung; Eun Sil Lee; Jeong Sig Kim; Gyu Yeon Choi; Jeong Jae Lee; Im Soon Lee Journal: Obstet Gynecol Sci Date: 2017-03-16