Efficacy and safety of Menorest ® in two positive-controlled studies

Abstract

Objectives: To evaluate the safety and efficacy of Menorest ® 50 in two clinical trials. Methods: Menorest ® 50 was evaluated in two trials: the first was a parallel-group, randomized double-bind study vs. Premarin ® 0.625 mg/day in 214 women while the second was a parallel-group, open-label trial versus Estraderm TTS ® 50 in 205 women. Results: In both studies there was a significant decrease in the mean number of hot flushes/day compared with baseline but no significant differences between treatments. The severity of hot flushes and the incidence and severity of other menopausal symptoms such as sweats, palpitations, headaches, depression, tiredness, vaginitis, loss of libido and dyspareunia were reduced to the same extent by all treatments. There were no significant differences between the different treatments as far as serum oestradiol or the incidence of systemic adverse events were concerned. In addition, small positive effects of total cholesterol and high-density lipoproteins were observed in the first study. Only a small reduction in cholesterol was seen in the second study in both groups but Menorest ® appeared to be better tolerated and a lower incidence of erythema, pruritus and other topic adverse events was reported. In addition, the twice-weekly application of Menorest ® was found to be convenient. Conclusions: Menorest ® appears to be as equally effective as oral and transdermal oestradiol as far as reduction in the incidence and severity of menopausal symptoms is concerned. It was safe and also better tolerated than Estraderm ®.