NCT00137371已完成3 期
Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administered Vaginally in Postmenopausal Women With Atrophic Vaginitis
Wyeth is now a wholly owned subsidiary of Pfizer49 个研究点 分布在 2 个国家目标入组 480 人开始时间: 2005年8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
- 480
- 试验地点
- 49
- 主要终点
- To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.
研究概览
简要总结
This protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated estrogen cream (PVC) given vaginally in postmenopausal women with atrophic vaginitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Generally healthy postmenopausal women with symptoms of atrophic vaginitis including vaginal dryness, vaginal itching, vaginal burning, and/or painful intercourse.
- •The subject must have a clinical diagnosis of atrophic vaginitis and an intact uterus.
排除标准
- •Women who do not have a clinical diagnosis of atrophic vaginitis.
结局指标
主要结局
To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.
次要结局
- To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health.
研究者
研究点 (49)
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