NCT00234819已完成3 期
A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogen Combinations for Treatment of Vasomotor Symptoms Associated With Menopause
Wyeth is now a wholly owned subsidiary of Pfizer7 个研究点 分布在 1 个国家目标入组 325 人开始时间: 2005年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 325
- 试验地点
- 7
- 主要终点
- Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards.
研究概览
简要总结
The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective in the treatment of moderate to severe vasomotor symptoms associated with menopause.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Generally healthy, postmenopausal women, aged 40 to 64, with last natural menstrual period completed at lease 6 months ago
- •Intact uterus
- •Seeking treatment for hot flushes and experiencing 7 moderate to severe hot flushes per day or 50 per week
排除标准
- •History of active presence of thrombophlebitis, thrombosis, thromboembolic disorders
- •History of active presence of stroke, TIA, heart attack or ischemic heart disease
- •History of melanoma, breast or any gynecologic cancer at any time; history of any other cancer within the past 5 years
结局指标
主要结局
Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards.
次要结局
- Breast pain throughout the 12 week study, as reported daily on subject diary cards. Sleep scales and sleep quantity at week 4 and week 12, as indicated on a subject-completed questionnaire.
研究者
研究点 (7)
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