临床试验/NCT00675688

NCT00675688已完成3 期

A Double-Blind, Randomized, Placebo- and Active-Controlled Safety and Efficacy Study of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 3,544 人开始时间: 2002年4月最近更新: 2008年5月12日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 3,544
主要终点: To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 40 Years 至 75 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Generally healthy, postmenopausal women aged 40 - 75 years inclusive
•Intact uterus
•Last natural menstrual cycle (without exogenous hormone therapy) completed at least 12 consecutive months before screening

排除标准

•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
•Additional criteria applies.

研究组 & 干预措施

A

Experimental

干预措施: Bazedoxifene/Conjugate Estrogens (CE) (Drug)

B

Active Comparator

干预措施: Raloxifene (Drug)

C

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women.

时间窗: one year

次要结局

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.(one year)

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

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