Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
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The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.
To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women. [ Time Frame: one year ]
Secondary Outcome Measures :
To evaluate the efficacy of Bazedoxifene/CE combinations in preventing osteoporosis. To evaluate the effects of Bazedoxifene/CE combinations on vaginal atrophy, metabolic parameters, uterine bleeding, vasomotor symptoms and quality of life indices. [ Time Frame: one year ]
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Layout table for eligibility information
Ages Eligible for Study:
40 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Generally healthy, postmenopausal women aged 40 - 75 years inclusive
Last natural menstrual cycle (without exogenous hormone therapy) completed at least 12 consecutive months before screening
A history or active presence of thrombophlebitis, thrombosis or thromboembolic disorders
A history or active presence of cerebrovascular accident, stroke, or transient ischemic attack
A history or active presence of malignancy, or treatment for malignancy, within the previous 10 years