Abstract No: 55 by hLuYC1X

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									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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