A double-blind comparative study of Estraderm and Premarin in the amelioration of postmenopausal symptoms.
Patients whose postmenopausal symptoms were being satisfactorily controlled with conjugated equine estrogens, either 0.625 mg/day (n = 57) or 1.25 mg/day (n = 67), participated in a study that compared the efficacy of these oral regimens with that of 17 beta-estradiol, 0.1 mg/day, administered through intact skin. The study was a multicenter, double-blind, randomized, parallel-group trial during which two thirds of the patients who received each dosage of conjugated equine estrogens were changed to an estradiol transdermal system while the remainder continued with conjugated equine estrogens. A total of 124 patients was included in the analysis of efficacy. The analysis revealed no significant differences between the estradiol transdermal system and conjugated equine estrogens in control of hot flushes or other postmenopausal symptoms and no statistically significant differences between treatment groups in regard to estrogen-related side effects. Minor topical reactions to the transdermal systems were reported during only about 20% of study weeks. Thus, transdermal estradiol, 0.1 mg/day, appears to be equally effective as conjugated equine estrogens, 0.625 or 1.25 mg/day, for controlling postmenopausal symptoms and is well tolerated.
Place
V A
VA
Powers
M
M
Darley
P E
PE
Schenkel
L
L
Good
W R
WR
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D002979:Climacteric / Q000187:drug effects*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D012867:Skin; D014592:Uterine Hemorrhage / Q000139:chemically induced
D004966:Estrogens, Conjugated (USP); D004958:Estradiol