EFFICACY AND TOLERANCE OF MENOREST(R) COMPARED TO PREMARIN(R) IN THE TREATMENT OF POSTMENOPAUSAL WOMEN - A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, DOUBLE-DUMMY STUDY

Two-hundred and fourteen (214) menopausal women with moderate to sever e vasomotor symptoms, aged 40-65 years, were randomised. After a 4-wee k treatment-free period, each woman received a continuous regimen of M enorest(R) 50 twice weekly or Premarin(R) 0.625 mg daily, for 12 weeks . Didrogesterone 10 mg was also given to all women for 12 days of ever y 28-day cycle. The objectives were to compare the efficacy and safety profiles of Menorest(R) and an oral estrogen. A statistically signifi cant reduction in the mean number of hot flushes occurred in each grou p compared to baseline with a decrease from 7.1 at baseline to 0.9 at 12 weeks in the Menorest(R) group, and from 6.7 to 0.5 in the oral est rogen group; there was no statistically significant difference between the two groups (P = 0.36). With each successive treatment cycle, ther e was a continuous improvement in the number of hot flushes. The incid ence and severity of menopausal symptoms were reduced in the same mann er in both groups. There were no statistically significant differences in the mean plasma estradiol and estrone concentrations between the t wo treatment groups after 10 weeks of therapy, The mean estradiol to e strone ratio was similar in both groups, as was the number of adverse events observed. In summary, Menorest(R) was as effective as an oral e strogen in alleviating menopausal symptoms.