EFFICACY AND SAFETY OF A 7-DAY, TRANSDERMAL ESTRADIOL DRUG-DELIVERY SYSTEM - COMPARISON WITH CONJUGATED ESTROGENS AND PLACEBO

Objective-To evaluate the efficacy and safety of a new, seven-day, tra nsdermal estradiol system in healthy postmenopausal women with hot flu shes. Methods-Two studies are described. In the first study, subjects were randomized to treatment with a 0.05 mg/day estradiol patch, a 0.1 mg/day estradiol patch, or a placebo patch; and in the second study, to treatment with either of the two estradiol patches or oral conjugat ed estrogens (as Premarin(R)) 0.625 mg/day. Efficacy was evaluated on the basis of diary entries recording hot-flush frequency and severity. Subjects' and investigators' global assessments of treatment efficacy were recorded at follow-up visits. Results-In Study 1, both the 0.05- mg and 0.1-mg estradiol patches were significantly more effective than placebo in reducing hot flushes and were associated with higher globa l assessments. In Study 2, all three active treatments produced a sign ificant reduction in the number of hot flushes compared with baseline. There were no statistically significant between-group differences, al though the response to the 0.1-mg estradiol patch was greater. and to the 0.05-mg estradiol patch less, than the response to conjugated estr ogens. The patches were generally well tolerated. Skin irritation from the patch was the most common adverse experience in both studies. Con clusion-The new, seven-day, transdermal system effectively and safely treats postmenopausal vasomotor symptoms.