A randomized study to compare the effectiveness, tolerability, and acceptability of two different transdermal estradiol replacement therapies. The Transdermal HRT Investigators Group.
This randomized trial was designed to assess the efficacy, tolerability, and acceptability of two different transdermal estradiol replacement therapies: Cilag Estradiol-TTS (a matrix system) and Ciba-Geigy Estradiol-TTS (a reservoir system). Five hundred and fourteen patients were evaluable for efficacy, and all patients who had received the study medications were evaluated for safety (n = 530). Both treatments significantly improved systemic and urogenital symptoms as evidenced by a decrease in the number of hot flushes and the Kupperman Index score; there was no difference in effectiveness between the two treatments. Safety evaluation revealed a low incidence of adverse events, mainly compatible with exogenously administered estrogen and progestagen. Endometrial biopsies at the end of treatment were similar between groups and consistent with balanced hormone replacement therapy. Analyses of acceptability data revealed a low incidence of skin reactions and an added benefit with the Cilag-Estradiol-TTS patch in terms of convenience owing to the adhesiveness of the patch. In conclusion, both transdermal estradiol replacement therapies were effective and well tolerated in the treatment of postmenopausal estrogen deficiency symptoms, and the Cilag Estradiol-TTS patch had an advantage in terms of convenience and adhesiveness.
D000279:Administration, Cutaneous; D002979:Climacteric / Q000187:drug effects; D004361:Drug Tolerance; D004848:Epithelium / Q000187:drug effects; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D015914:Estrogen Replacement Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D010352:Patient Dropouts; D017060:Patient Satisfaction; D016037:Single-Blind Method; D014554:Urination / Q000187:drug effects; D014621:Vagina / Q000166:cytology / Q000187:drug effects
D004958:Estradiol