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Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms
Date:7/27/2009

led Phase 3 study that evaluated 3,397 healthy, postmenopausal women with an intact uterus aged 40 to 75 years. The primary end point of the SMART-1 trial was incidence of endometrial hyperplasia at one year. Secondary end points included bone mineral density (BMD) at two years, menopausal vasomotor symptoms at four and 12 weeks, vaginal maturation index at six months, menopause-related quality of life measures, and overall safety and tolerability. The results were published concurrently across four manuscripts at http://www.fertstert.org/inpress.

Titles and Summary of Findings From Published Manuscripts

1. Endometrial Protection in Menopausal Therapy with a Tissue Selective Estrogen Complex (TSEC) Containing Bazedoxifene/Conjugated Estrogens (Pickar JH, et al)

To evaluate endometrial effects, biopsies were performed at screening and at months six, 12, and 24, or when subjects withdrew from the study and more than three months had elapsed since their last assessment. Treatment with BZA/CE doses being considered for therapeutic use were associated with rates of endometrial hyperplasia <1%. These rates were not significantly different from those reported with placebo over two years of study.

2. Bazedoxifene/Conjugated Estrogens (BZA/CE): Incidence of Uterine Bleeding in Postmenopausal Women (Archer DF, et al)

To evaluate the effect of treatment with BZA/CE on uterine bleeding, trial participants were asked to record in a diary whether or not they experienced bleeding and/or spotting. The mean number of bleeding or spotting days with BZA/CE was not statistically different from placebo over two years of therapy.

3. Evaluation of Bazedoxifene/Conjugated Estrogens (BZA/CE) for the Treatment
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SOURCE Wyeth
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