NCT01064453已完成不适用
Angeliq Regulatory Post Marketing Surveillance
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 4,078
- 主要终点
- Adverse event collection
研究概览
简要总结
Angeliq regulatory Post-Marketing Surveillance (PMS) is to get data about safety and efficacy in real practice for the indication approved by Korea Food and Drug Administration (KFDA). This is non-interventional , prospective, multi-center study.Target number of patients is 4500.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women more than 1 year postmenopause
- •Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis
排除标准
- •Undiagnosed genital bleeding
- •Known, past or suspected cancer of the breast
- •Known or suspected estrogen-dependent malignant tumors (e.g. endometrial cancer)
- •Untreated endometrial hyperplasia
- •Previous idiopathic or current venous thromboembolism (e.g. deep venous thrombosis, pulmonary embolism)
- •Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
- •Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal
- •Porphyria
- •Severe renal insufficiency or acute renal failure
- •Known hypersensitivity to the active substances or to any of the excipients
研究组 & 干预措施
Group 1
干预措施: E2/DRSP (Angeliq, BAY86-4891) (Drug)
结局指标
主要结局
Adverse event collection
时间窗: At each visit of patient during observational period (6 months)
次要结局
- Improvement of menopausal symptoms(After 6 months or at discontinuation of Angeliq (At earlier point))
研究者
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