Efficacy on climacteric symptoms of a continuous combined regimen of 1 mg 17β-estradiol and trimegestone versus two regimens containing 1 or 2 mg 17β-estradiol and norethisterone acetate

Abstract

Objectives. To compare the efficacy of a continuous combined regimen of 1 mg 17β-estradiol (17β-E2) and 0.125 mg trimegestone (TMG) with two continuous combined 17β-E2/norethisterone acetate (NETA) combinations in the relief of climacteric symptoms in postmenopausal women.Study design. This was a randomized, double-blind, multicenter study conducted in 13 countries over a 2-year period. Healthy postmenopausal women with an intact uterus were treated with 1 mg 17β-E2/0.125 mg TMG, 2 mg 17β-E2/1 mg NETA or 1 mg 17β-E2/0.5 mg NETA for up to 26 cycles, each of 28 days.Results. The 1 mg 17β-E2/0.125 mg TMG combination was effective in significantly reducing the mean daily number and severity of hot flushes and in reducing the number of night sweats from cycle 1 onward. No overall significant differences between this regimen and the comparators were detected. Other efficacy variables, including the Kupperman index, psychofunctional disorders and quality-of-life sub-scales, experienced a similar improvement from baseline with all treatments.Conclusion. Continuous combined 1 mg 17β-E2/0.125 mg TMG provides relief of menopausal symptoms that is non-inferior to both 17β-E2/NETA combinations. Furthermore, trimegestone appeared to provide a better improvement of depressive mood than 0.5 mg NETA when combined with 1 mg 17β-estradiol.