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. The Esclim Study Group.
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 17beta-estradiol per 24 hours, in the treatment of moderate to severe vasomotor symptoms.


METHODS
In this double-blind, placebo-controlled, parallel-group, multicenter trial, 196 highly symptomatic menopausal women received 12 weeks of continuous unopposed treatment with 1 of the 3 dosages of Esclim or a matching placebo patch.


RESULTS
The reduction in frequency of moderate to severe vasomotor symptoms 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 Esclim 25 group. Symptom severity was also reduced. Estrogen-related adverse events, particularly metrorrhagia and endometrial hyperplasia, were less frequent in the Esclim 25 group than in the higher-dosage groups.


CONCLUSIONS
All 3 dosages of Esclim were effective in the treatment of vasomotor symptoms. The efficacy and safety of Esclim 25 indicate a good risk-benefit ratio.
Utian
W H
WH
University Hospitals of Cleveland, Ohio, USA.
Burry
K A
KA
Archer
D F
DF
Gallagher
J C
JC
Boyett
R L
RL
Guy
M P
MP
Tachon
G J
GJ
Chadha-Boreham
H K
HK
Bouvet
A A
AA
D000279:Administration, Cutaneous; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004958:Estradiol / Q000008:administration & dosage* / Q000494:pharmacology*; D015914:Estrogen Replacement Therapy; D005260:Female; D019584:Hot Flashes; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D012720:Severity of Illness Index; D014481:United States
D004958:Estradiol