A DOUBLE-BLIND, DOUBLE-DUMMY, COMPARATIVE-STUDY OF MENOREST 50(R) VERSUS PREMARIN(R) 0.625MG IN THE TREATMENT OF MENOPAUSAL SYMPTOMS AND THE PREVENTION OF BONE LOSS IN PATIENTS WITH MENOPAUSAL SYMPTOMS

Thirty-two menopausal women entered the study (16 in each treatment gr oup), of whom 24 completed the trial. The objectives were to investiga te the long term efficacy and the local and systemic tolerance of Meno rest 50(R) and Premarin(R) in the control of menopausal symptoms. Afte r a 4-week treatment-free run-in period, patients were treated with co ntinuous estrogen therapy (a twice-weekly application with Menorest 50 (R) or a daily oral administration of Premarin(R) 0.625mg) for 1 year, plus a sequential progestin. The main efficacy criterion was the redu ction in the mean number of hot flushes per day at 12 months. This stu dy was considered to be a pilot study to collect data on changes in th e bone mineral density of lumbar spine (L1-L4) assessments from baseli ne to weeks 30 and 56. Menorest 50(R) and Premarin(R) produced similar results in the relief of menopausal symptoms over the 1-year period o f treatment. The mean number of hot flushes per day decreased from 6.9 at baseline to 0.5 at 12 weeks and 0.1 at 12 months in the Menorest 5 0(R) group, and from 7.0 to 0.3 and 0.0, respectively, in the Premarin (R) group. The lumbar spine and hip densitometry results revealed that Menorest 50(R) prevented bone loss to the same extent as Premarin(R). Tolerance was similar, with approximately the same number of patients with adverse events, severe adverse events and related-to-study-drug adverse events in both groups. Menorest 50(R) and Premarin(R) 0.625mg demonstrated similar results over the 1-year treatment period in reduc ing the mean number of hot flushes and the severity score of menopausa l symptoms, including vasomotor, psychological and urogenital symptoms .