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临床试验/NCT01705249
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®

Novo Nordisk A/S1 个研究点 分布在 1 个国家目标入组 191 人开始时间: 2001年8月14日最近更新:
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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
研究概览研究设计入排标准研究组 & 干预措施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

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

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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Bleeding Profile With Continuous Hormone Replacement... | 临床试验