NCT00332553已完成2 期
Study of Vasomotor Symptoms in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Compare the number of vasomotor symptoms at 12 weeks between those women taking the combination of raloxifene with oral estradiol versus those taking raloxifene alone.
研究概览
简要总结
This pilot study was designed to explore the effects of combined treatment with raloxifene HCl 60 mg and oral 17 beta-estradiol 1mg/day on the number of vasomotor episodes (hot flashes plus night sweats) in postmenopausal women discontinuing continuous combined hormone replacement therapy (ccHRT) compared to women treated with raloxifene HCl 60 mg alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Post menopausal women, 50-70 years of age
- •Had taken ccHRT for at least 6 months prior to study entry
- •No unexplained vaginal bleeding in the 3 months prior to study entry
- •Understand and sign an informed consent document
排除标准
- •Prior hysterectomy
- •Endometrial thickness (excluding endometrial fluid) greater than 8 mm or endometrial fluid greater than or equal to 4 mm at study entry
- •Abnormal Pap smear at study screening or within the preceding 3 years
- •Abnormal transvaginal ultrasound result at study screening
- •Past or current history of malignant neoplasms
结局指标
主要结局
Compare the number of vasomotor symptoms at 12 weeks between those women taking the combination of raloxifene with oral estradiol versus those taking raloxifene alone.
次要结局
- Determine the effect of treatment with combined raloxifene and estradiol compared with raloxifene alone on the severity of vasomotor symptoms as well as on the frequency and severity of hot flashes and night sweats
- Determine the effects of treatment with combined raloxifene and estradiol in postmenopausal women on endometrial and general safety
研究者
研究点 (1)
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