Effects of period-free hormone replacement therapy in postmenopausal women in Taiwan

Abstract

Background: To compare the effects of continuous combined hormone replacement therapy (Kliogest) and placebo on climacteric symptoms, bone turnover markers, serum lipid profiles and the safety of Kliogest.

Methods: This is a 4-month, single-centre, double-blind, placebo-controlled clinical study. Fifty-six healthy volunteer women with intact uterus, between six months and three years after a natural menopause, were recruited and randomised into two groups to have blood and urine laboratory test for assessment of bone resorption marker of deoxypyridinoline, bone formation marker of bone specific alkaline phosphatase, lipid profile including total cholesterol, high-density lipoprotein, low-density lipoprotein and triglyceride, and menopausal symptoms. Information was taken at initial visit and 1, 2 and final follow-up after taking medication.

Results: Continuous Kliogest treatment resulted in significant reduction in menopausal symptoms, as scored by Integrated Greene Climacteric Scale and in the psychological, somatic and vasomotor subscales scores (p = 0.009). Kliogest reversed the negative trends in lipoprotein profiles by lowering total cholesterol (p < 0.001), low-density lipoprotein cholesterol (p < 0.001), and triglyceride (p = 0.004), but decreasing high-density lipoprotein cholesterol (p = 0.002). A significant reduction in bone resorption marker, deoxypyridinoline, was also observed in the Kliogest group (p < 0.001). There was no report of serious adverse events, endometrial hyperplasia or cancer in the Kliogest treated patients.

Conclusions: Four-month treatment with Kliogest resulted in an improvement in menopausal symptoms and lipid profiles as well as reduction in bone loss.