NCT00141557终止2 期
A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 133
- 试验地点
- 78
- 主要终点
- Change from baseline in the total score of the Menopause Rating Scale (MRS)
研究概览
简要总结
To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets
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 (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hysterectomized, menopausal women between the ages of 30 and 65 years of age (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: esterified estrogens 1.25mg and methyltestosterone 2.5mg (Drug)
2
Active Comparator
干预措施: Esterified estrogens 1.25 mg (Drug)
结局指标
主要结局
Change from baseline in the total score of the Menopause Rating Scale (MRS)
时间窗: 12 weeks
次要结局
- Change from baseline in the domain and individual item scores of the MRS(12 weeks)
- Change from baseline in the domain scores of the MENQOL(monthly for 3 months)
- Comparison of changes in hormone levels and correlation with changes in the MRS(12 weeks)
研究者
研究点 (78)
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