Efficacy on climacteric symptoms and safety of low dose estradiol transdermal matrix patches - A randomized, double-blind placebo-controlled study

Two estradiol (E-2) transdermal patches releasing 25 mu g/day E-2 (D-25) or 37.5 mu g/day E-2 (D37.5) were compared to a placebo patch on 156 patients in natural or surgical menopause suffering from at least 5 hot flushes per day, randomly and blindly assigned to three parallel groups of 52 patients each, to be treated continuously for 12 weeks, without progestin oppositio n. "Responders" (patients with less than 3 hot flushes per day at the end of t reatment), were 82 % and 90 % under D-25 or D-37.5, respectively, both sign ificantly (p < 0.001) more than under placebo (44 %). Comparable efficacy w as observed on severity of hot flushes, Kupperman Index and on the self-rat ed efficacy. Systemic adverse events occurred in 10 %, 10 % and 8 % of patients, respect ively, under D-25, D-37.5 or placebo. Occasional mild and transient itching and/or erythema on the site of application was reported by few patients an d did never require discontinuation of application. In conclusion D-25 and D-37.5 were significantly more effective than placebo in relieving climacte ric symptoms and were systemically and locally as well tolerated as placebo . D-25 (Demestril(R) 25) releasing 25 mu g/day E-2 can therefore be recomme nded for low-dosed estrogen replacement therapy.