A Double-Blind, Double-Dummy, Comparative Study of Menorest 50® versus Premarin® 0.625mg in the Treatment of Menopausal Symptoms and the Prevention of Bone Loss in Patients with Menopausal Symptoms

Summary

Thirty-two menopausal women entered the study (16 in each treatment group), of whom 24 completed the trial. The objectives were to investigate the long term efficacy and the local and systemic tolerance of Menorest 50® and Premarin® in the control of menopausal symptoms. After a 4-week treatment-free run-in period, patients were treated with continuous estrogen therapy (a twice-weekly application with Menorest 50® or a daily oral administration of Premarin® 0.625mg) for 1 year, plus a sequential progestin. The main efficacy criterion was the reduction in the mean number of hot flushes per day at 12 months. This study was considered to be a pilot study to collect data on changes in the bone mineral density of lumbar spine (L1-L4) assessments from baseline to weeks 30 and 56. Menorest 50® and Premarin® produced similar results in the relief of menopausal symptoms over the 1-year period of 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 50® group, and from 7.0 to 0.3 and 0.0, respectively, in the Premarin group. The lumbar spine and hip densitometry results revealed that Menorest 50® prevented bone loss to the same extent as Premarin®. 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® and Premarin® 0.625mg demonstrated similar results over the 1-year treatment period in reducing the mean number of hot flushes and the severity score of menopausal symptoms, including vasomotor, psychological and urogenital symptoms.