NCT01705249已完成4 期
Bleeding Profile With Continuous Hormone Replacement Therapy in Postmenopausal Women: A Prospective, Open, Multicenter Trial of Activelle® Treatment Following Switch From Trisekvens®
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
- 191
- 试验地点
- 1
- 主要终点
- Postmenopausal women's acceptance of bleeding
研究概览
简要总结
This study is conducted in Europe. The aim of this study is to investigate the bleeding profile after switch from Trisekvens® to Activelle® (1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women
- •At least 3 months on Trisekvens® before screening period
- •Ability to understand and comply with the protocol requirements
排除标准
- •Less than 12 months or more than 36 months postmenopausal judged by the Investigator
- •Known, suspected, or past history of hormone dependent tumor/cancers
- •Deep venous thrombosis, active thrombophlebitis, thromboembolic disorders, cerebrovascular accidents or past history of these conditions
- •Ischemic heart disease or myocardial infarction within 6 months prior to randomization
研究组 & 干预措施
estradiol / norethisterone acetate
Experimental
干预措施: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA) (Drug)
结局指标
主要结局
Postmenopausal women's acceptance of bleeding
时间窗: After 24 weeks of treatment
次要结局
- Bleeding profile in postmenopausal women(After 24 weeks of treatment)
- Acceptance of hot flushes and breast tenderness(After 24 weeks of treatment)
研究者
研究点 (1)
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