NCT00195455已完成4 期
A Prospective Open Label Study to Evaluate Vasomotor Symptoms Control and Bleeding Patterns With a Continuous Regimen of a New Progestin Trimegestone 0.125 mg and 17 b Estradiol 1 mg (Totelle),as HT on Postmenopausal Women
Wyeth is now a wholly owned subsidiary of Pfizer6 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2005年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 6
- 主要终点
- To assess vasomotor symptoms control with a continuous regimen of 17 b estradiol 1mg and Trimegestone (TMG) 0.125 mg.
研究概览
简要总结
The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous regimen 17 b estradiol/trimegestone combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Generally healthy postmenopausal women 45 to 55 years of age inclusive, with at least 1 year of natural occurring amenorrhea, with vasomotor symptoms, with at least 4 hot flushes per day
- •Intact uterus
排除标准
- •Known or suspected breast carcinoma or estrogen-dependent neoplasm
- •Undiagnosed abnormal genital bleeding
结局指标
主要结局
To assess vasomotor symptoms control with a continuous regimen of 17 b estradiol 1mg and Trimegestone (TMG) 0.125 mg.
次要结局
- Study bleeding patterns throughout the treatment period (6 months)
- Evaluate changes in the Menopause-Specific Quality of Life Questionnaire
研究者
研究点 (6)
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