Abstract No: 82 HORMONE REPLACEMENT THERAPY (HRT) WITH 1MG NORETHINDRONE ACETATE (NA)/5MCG ETHINYL ESTRADIOL (EE) (FEMHRT) PROVIDES GREATER PROTECTION AGAINST BREAKTHROUGH BLEEDING VERSUS 0.625MG COMBINED EQUINE ESTROGENS (CEE)/2.5MG MEDROXYPROGESTERONE (MPA) (PREMPRO) 1 D.J. Portman, 2B.S. Shumel, 3J.P. Symons 1 Columbus Center for Women's Health, 2Pfizer Pharmaceuticals Group, 3 Pfizer Global Research And Development, USA Objective: To compare the effects of two continuous combined HRT treatments, NA/EE (femhrt) versus CEE/MPA (Prempro) on vaginal bleeding in postmenopausal women. Methods: This was a 12-month randomized, placebo-controlled, comparative study in women who had become menopausal within 5 years of the start of enrollment, had not experienced vaginal bleeding for at least 6 months, and were free of significant current or historical disease. Active treatments comprised blinded 1mg NA/5mcg EE (femhrt; n=121) or open-label 0.625mg CEE/2.5mg MPA (Prempro; n=119). Subjects recorded the occurrence of breakthrough bleeding, based on standard definitions, in daily diaries. This study reports data for the mean percentage of women who did not experience bleeding during Months 1, 3, 6, 9, and 12 of treatment. Analyses were conducted on the intent-to-treat population using last observation carried forward methodology. Results: Baseline patient demographics were similar in both the NA/EE and CEE/MPA treatment groups. The incidence of 'no bleeding' for subjects in the active treatment groups was significantly higher in patients receiving NA/EE than in those receiving CEE/MPA at Months 1, 3, and 6 (p less than 0.05). Additionally, at Months 9 and 12 the incidence of no bleeding was numerically higher in patients receiving NA/EE than in those receiving CEE/MPA. Conclusions: 1mg NA/5mcg EE provides significantly more effective control of bleeding than 0.625mg CEE/2.5mg MPA during the first 6 months of treatment. As the majority of women who discontinue HRT do so within the first few months of treatment initiation,1 this finding could have important clinical implications. 1. Karakoc B and Erenus M. Menopause 1998.
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