OBJECTIVE: to compare the efficacy, tolerability and user preference of Aerodiol intranasal and transdermal patch administration of 17 beta-estradiol for climacteric symptoms. METHODS: an open-label, multicenter, crossover trial in which recently postmenopausal women were randomized to receive either Aerodiol 300 microg daily (n=176), or transdermal 17 beta-estradiol (reservoir patches delivering 50 microg/day), 2 patches per week (n=185), for 12 weeks, followed by 4 weeks of the alternative treatment. Efficacy was assessed primarily by the Kupperman index at the end of each treatment period. User satisfaction was assessed by questionnaire at weeks 12 and 16, and at week 16 the women chose which treatment they preferred to use for a further 40-week period. RESULTS:Aerodiol and transdermal patch therapy produced marked and similar reductions in the Kupperman index and the incidence of hot flushes at weeks 12 and 16. The reduction in the Kupperman index at week 12 was statistically equivalent for the two treatments. The tolerability of both treatments was good, with similar numbers of emergent adverse events reported in both groups. The incidence of moderate or severe mastalgia, however, was significantly lower with Aerodiol (P=0.02). Significantly more women chose to continue treatment with Aerodiol than with the transdermal patch (66 vs. 34%, P<0.001). When all women had experienced both treatments, reported levels of satisfaction were significantly higher with Aerodiol than with transdermal therapy (P<0.001 for all six categories assessed). CONCLUSIONS: Aerodiol and transdermal patch treatments were of similar efficacy and tolerability. Levels of user preference and satisfaction, however, were higher with Aerodiol, which should contribute towards good long-term compliance with this therapy.
RCT Entities:
OBJECTIVE: to compare the efficacy, tolerability and user preference of Aerodiol intranasal and transdermal patch administration of 17 beta-estradiol for climacteric symptoms. METHODS: an open-label, multicenter, crossover trial in which recently postmenopausal women were randomized to receive either Aerodiol 300 microg daily (n=176), or transdermal 17 beta-estradiol (reservoir patches delivering 50 microg/day), 2 patches per week (n=185), for 12 weeks, followed by 4 weeks of the alternative treatment. Efficacy was assessed primarily by the Kupperman index at the end of each treatment period. User satisfaction was assessed by questionnaire at weeks 12 and 16, and at week 16 the women chose which treatment they preferred to use for a further 40-week period. RESULTS:Aerodiol and transdermal patch therapy produced marked and similar reductions in the Kupperman index and the incidence of hot flushes at weeks 12 and 16. The reduction in the Kupperman index at week 12 was statistically equivalent for the two treatments. The tolerability of both treatments was good, with similar numbers of emergent adverse events reported in both groups. The incidence of moderate or severe mastalgia, however, was significantly lower with Aerodiol (P=0.02). Significantly more women chose to continue treatment with Aerodiol than with the transdermal patch (66 vs. 34%, P<0.001). When all women had experienced both treatments, reported levels of satisfaction were significantly higher with Aerodiol than with transdermal therapy (P<0.001 for all six categories assessed). CONCLUSIONS:Aerodiol and transdermal patch treatments were of similar efficacy and tolerability. Levels of user preference and satisfaction, however, were higher with Aerodiol, which should contribute towards good long-term compliance with this therapy.