Estradiol 1 mg and drospirenone 2 mg as hormone replacement therapy in postmenopausal Chinese women

2011 
Objectives Drospirenone is a novel progestogen that, combined with 17β-estradiol, reduces the frequency and severity of menopausal vasomotor symptoms (VMS) in different populations. This double-blind, multicenter study compared the efficacy, safety and tolerability of 2 mg drospirenone/1 mg estradiol (DRSP/E2) vs. placebo in Chinese postmenopausal women with moderate to severe VMS.Methods Women, aged 45–65 years, were randomized to DRSP/E2 (n = 183) or placebo (n = 61) once daily for four 28-day cycles. Changes in the frequency and severity of hot flushes were analyzed as primary variables, together with other climacteric and urogenital symptoms, clinical global improvement, adverse events and physical/gynecological parameters.Results Relative changes in numbers of hot flushes/week were −80.4% for DRSP/E2 vs. −51.9% for placebo (treatment difference −28.5%, p < 0.0001). There were trends toward a greater reduction in severity of hot flushes with DRSP/E2 treatment. Patients treated with DRSP/E2 were more o...
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