NCT01386281已完成不适用
Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)
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
- 506
- 主要终点
- Incidence of adverse drug reactions and serious adverse events in subject who received Julina
研究概览
简要总结
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Julina for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in clinical practice. A total 100 patients will be recruited and followed 3 years since starting Julina administration.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who received Julina for postmenopausal osteoporosis
排除标准
- •Patients who are contraindicated based on the product label
研究组 & 干预措施
Group 1
Drug (incl. Placebo)
干预措施: E2 transdermal (Julina, BAY86-5435) (Drug)
结局指标
主要结局
Incidence of adverse drug reactions and serious adverse events in subject who received Julina
时间窗: After Julina administration, upto 1 year
次要结局
- Change from baseline in with/without vaginal atrophy at the end of Julina treatment(At baseline and at end of Julina treatment, upto 1 year)
- Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Julina(At baseline and after Julina administration, upto 1 year)
- Change from baseline in grad of hot flush and sweating at the end of Julina treatment(At baseline and at end of Julina treatment, upto 1 year)
研究者
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