ABSTRACT
The efficacy of the oral hormone replacement therapy (HRT) preparation estradiol valerate/levonorgestrel (EV/LNG, Klimonorm) in the alleviation of the menopausal complaints of peri- and postmenopausal Thai women was studied in a prospective, open, uncontrolled phase IV clinical trial. Of the 50 peri- or postmenopausal women screened, 39 completed the study. From them 31 were postmenopausal and 8 perimenopausal. The participants received EV/LNG over a period of 6 cycles. The Menopause Rating Scale II (MRS II) was used to assess the effect of EV/LNG on the menopausal symptoms. The changes in the main parameters of the MRS II during the treatment with EV/LNG showed that the general score decreased by 34.9 per cent after 3 months and was kept at the same value after 6 months of treatment. The somato-vegetative complaints decreased by 32.5 per cent after 3 months and by 35 per cent after 6 months. The psychological complaints decreased by 34.1 per cent after 3 months and by 32.9 per cent after 6 months. The urogenital complaints decreased by 29.3 per cent after 3 months, and remained at the same level after 6 months of treatment. In conclusion, the 6-months administration of the oral HRT preparation estradiol valerate/levonorgestrel caused a considerable alleviation of the climacteric symptoms in menopausal women.