Clinical equivalence of intranasal estradiol and oral estrogens for postmenopausal symptoms

Abstract

Objectives: The aim was to demonstrate the equivalent efficacy of intranasal estradiol (Aerodiol Servier, Istanbul, Turkey) 300 mg/day relative to a standard oral estradiol therapy of 2 mg/day and to assess the therapeutic value of the potential benefits of Aerodiol.

Methods: Two hundred and one postmenopausal women with severe menopausal symptoms were recruited to the trial. Women received either intranasal Aerodiol 300 microg/day (one spray delivery of 150 microg per nostril) or an oral estradiol 2 mg for 24 weeks. Severity of symptoms were compared based on the Kupperman index (KI) at the end of 24 weeks.

Results: The KI score decreased markedly in both groups between W0 and W24. At W24, the two treatments were shown to be statistically equivalent (P<0.001). The incidence of adverse events was very similar in both groups; those related to treatment were of mild or moderate intensity in 95% of cases for the nasal group and 90% for the oral group.

Conclusions: In conclusion, pulsed estrogen therapy using Aerodiol is safe, easily used and highly efficient in alleviating postmenopausal symptoms with a dose of 300 microg. The dose of 300 microg in one administration per day offers the optimal therapy whilst being easily adaptable to each patient's clinical response.