NCT00238732已完成3 期
A Double-Blind, Randomized, Placebo-and Active-Controlled Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogens Combinations for Treatment of Moderate to Severe Vulvar/Vaginal Atrophy in Postmenopausal Women
Wyeth is now a wholly owned subsidiary of Pfizer63 个研究点 分布在 1 个国家目标入组 650 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
- 650
- 试验地点
- 63
- 主要终点
- Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
研究概览
简要总结
The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 65 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 to 65 years
- •Intact uterus
- •At least 1 moderate to severe vulvar/vaginal symptom that is most bothersome
排除标准
- •Hypersensitivity to estrogens, endometrial hyperplasia, known or suspected estrogen-dependent neoplasia
- •Thrombophlebitis, thrombosis or thromboembolic disorders
- •Neuro-ocular disease
结局指标
主要结局
Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
Parabasal cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
次要结局
- Vaginal pH at screening, and weeks 4 and 12.
- Most bothersome moderate or severe vulvar/vaginal atrophy sympton at screening, and weeks 4 and 12.
研究者
研究点 (63)
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