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. STUDY DESIGN: 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. CONCLUSION: 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.
RCT Entities:
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. STUDY DESIGN: 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. CONCLUSION: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.
Authors: Wulf H Utian; David F Archer; Gloria A Bachmann; Christopher Gallagher; Francine n Grodstein; Julia R Heiman; Victor W Henderson; Howard N Hodis; Richard H Karas; Rogerio A Lobo; JoAnn E Manson; Robert L Reid; Peter J Schmidt; Cynthia A Stuenkel Journal: Menopause Date: 2008 Jul-Aug Impact factor: 2.953
Authors: Rogerio A Lobo; Serge Bélisle; William T Creasman; Nancy R Frankel; Neil F Goodman; Janet E Hall; Susan Lee Ivey; Sheryl Kingsberg; Robert Langer; Rebecca Lehman; Donna Behler McArthur; Valerie Montgomery-Rice; Morris Notelovitz; Gary S Packin; Robert W Rebar; MaryEllen Rousseau; Robert S Schenken; Diane L Schneider; Katherine Sherif; Susan Wysocki Journal: MedGenMed Date: 2006
Authors: Ana Marcia I S Gaudard; Sulani Silva de Souza; Maria E S Puga; Jane Marjoribanks; Edina M K da Silva; Maria R Torloni Journal: Cochrane Database Syst Rev Date: 2016-08-01
Authors: Manuel Cortés-Bonilla; Roberto Bernardo-Escudero; Rosalba Alonso-Campero; María T Francisco-Doce; Marcelino Hernández-Valencia; Cuauhtémoc Celis-González; Ricardo Márquez-Oñate; Peter Chedraui; Juan A Uribe Journal: Gynecol Endocrinol Date: 2015-06-10 Impact factor: 2.260