A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women

Solvay Pharmaceuticals79 个研究点分布在 1 个国家目标入组 350 人开始时间: 2004年6月最近更新: 2015年1月16日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Solvay Pharmaceuticals
入组人数: 350
试验地点: 79
主要终点: Change from baseline in the total score of the Menopause Rating Scale (MRS) at Week 12

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To determine whether treatment with ESTRATEST® H.S. 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

入排标准

年龄范围: 30 Years 至 65 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Menopausal women between the ages of 30 and 65 years (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

结局指标

主要结局

Change from baseline in the total score of the Menopause Rating Scale (MRS) at Week 12

次要结局

Change from baseline in the MRS at Week 12 & monthly change from baseline to Week 12 in the MENQOL; Comparison of changes in SHBG & testosterone & how these changes correlate with the MRS

研究者

发起方

Solvay Pharmaceuticals

申办方类型

Industry

研究点 (79)

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