NCT00145522已完成4 期
A Twelve 28-Day Cycles, Multicenter, Prospective, Randomized, Open, Blinded Endpoint, Parallel Group Study Comparing the Effect on Breast and Cardiovascular Metabolic Markers of Continuously Combined 17β-Estradiol/Dydrogesterone and Tibolone in Postmenopausal Women.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 11
- 主要终点
- IGF1 values after 12 cycles of 28 days
研究概览
简要总结
This study is to evaluate the effects of continuously combined 17b-estradiol/dydrogesterone in comparison with tibolone on the breast metabolic markers, in particular the total insulin-like growth factor-1 (IGF-1), in postmenopausal women.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Natural or surgical postmenopausal amenorrhea since ≥ 12 months,
- •non hysterectomized women, complaining of at least 14 hot flushes per week
排除标准
- •Known, suspected or history of breast cancer or hormone-dependent neoplasia,
- •undiagnosed genital bleeding,
- •venous or arterial history or presence of thromboembolism,
- •cerebrovascular disease
研究组 & 干预措施
1
Experimental
干预措施: 17ß-Estradiol/Dydrogesterone (Drug)
2
Active Comparator
干预措施: Tibolone (Drug)
结局指标
主要结局
IGF1 values after 12 cycles of 28 days
时间窗: 1 year
次要结局
- after 12 cycles of 28 days: other breast metabolic markers [IGFBP 1 and 3, SHBG, free estradiol, fasting insulin], breast tenderness and breast density, cardiovascular metabolic markers, menopausal symptoms and bleeding pattern(1 year)
研究者
研究点 (11)
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