NCT00472004已完成4 期
A Prospective, Randomized, Open Label Study To Compare The Efficacy, Safety And Tolerability Of 17-B Estradiol/Trimegestone CC 1 Mg (Totelle) And Tibolone (Livial) In Postmenopausal Women.
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2006年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Decreased of Vasomotor Symptoms [from baseline to six and twelve months]
研究概览
简要总结
This is a Phase IV prospective, randomized, open label, comparative, multicenter study in generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and Livial (Tibolone).
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
- 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
- •Last natural (without exogenous hormone therapy) menstrual cycle completed at least 12 consecutive months prior to screening and without any other kind of gynecological bleeding during this same period
- •At least 1 year of natural occurring amenorrhea
排除标准
- •Known or suspected estrogen-dependent neoplasia
- •Endometrial hyperplasia
- •Any malignancy with the exception of a history of basal cell carcinoma of the skin
研究组 & 干预措施
1
Active Comparator
17B Estradiol (1mg) / (0.125 mg) Trimegestone (TMG) Continuous combined, 1 Daily, 1 year duration
干预措施: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle) (Drug)
2
Active Comparator
Tibolone 2.5 mg 1 daily, 1 year duration
干预措施: Tibolone (Livial) (Drug)
结局指标
主要结局
Decreased of Vasomotor Symptoms [from baseline to six and twelve months]
时间窗: 1 year
次要结局
- Changes in Body Weight (from baseline to six and twelve months)(1 year)
- Quality of Life (from baseline to six and twelve months)(1 year)
- Treatment Adherence (from baseline to six and twelve months)(1 year)
- Breast Tenderness (from baseline to six and twelve months)(1 year)
研究者
研究点 (1)
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