Efficacy and safety of low, standard, and high dosages of an estradiol transdermal system (Esclim) compared with placebo on vasomotor symptoms in highly symptomatic menopausal patients
Wh. Utian et al., Efficacy and safety of low, standard, and high dosages of an estradiol transdermal system (Esclim) compared with placebo on vasomotor symptoms in highly symptomatic menopausal patients, AM J OBST G, 181(1), 1999, pp. 71-79
OBJECTIVE: Our purpose was to evaluate the efficacy and safety of 3 dosages
of Esclim, delivering 0.025 mg, 0.050 mg, or 0.100 mg 17 beta-estradiol pe
r 24 hours, in the treatment of moderate to severe vasomotor symptoms.
STUDY DESIGN: In this double-blind, placebo-controlled, parallel-group, mul
ticenter trial, 196 highly symptomatic menopausal women received 12 weeks o
f continuous unopposed treatment with 1 of the 3 dosages of Esclim or a mat
ching placebo patch.
RESULTS: The reduction in frequency of moderate to severe vasomotor symptom
s was statistically significant compared with placebo (P < .05) from week 2
onward in the Esclim 50 and 100 groups and from week 3 onward in the Escli
m 25 group. Symptom severity was also reduced. Estrogen-related adverse eve
nts, particularly metrorrhagia and endometrial hyperplasia, were less frequ
ent in the Esclim 25 group than in the higher-dosage groups.
CONCLUSION: All 3 dosages of Esclim were effective in the treatment of vaso
motor symptoms. The efficacy and safety of Esclim 25 indicate a good risk-b
enefit ratio.