跳至主要内容
临床试验/NCT01004809
NCT01004809已完成不适用

An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and Effectiveness of AVODART® Administered in Korean Androgenetic Alopecia Patients According to the Prescribing Information

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 712 人开始时间: 2010年4月29日最近更新:
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
入组人数
712
试验地点
1
主要终点
Occurrence of adverse event after dutasteride administration

研究概览

简要总结

Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in Korean androgenetic alopecia patients

详细描述

An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and effectiveness of dutasteride administered in Korean androgenetic alopecia patients according to the prescribing information

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 41 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Men (18-41 years of age) with male pattern hair loss (androgenetic alopecia)
  • Subjects with no experience of treatment using dutasteride
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol
  • Subjects who prescribed with dutasteride according to the Prescribing Information

排除标准

  • Considering the nature of observational study, GSK Korea encourages the doctors participating in this study to enrol the subjects prescribed with dutasteride following the locally approved Prescribing Information. Subject who give informed consent is enrolled. However, if institution waives the requirement for informed consent, informed consent is not required. In this case, monitoring does not proceed.

研究组 & 干预措施

Dutasteride

Patients administrated dutasteride with male hair loss

干预措施: Dutasteride (Drug)

结局指标

主要结局

Occurrence of adverse event after dutasteride administration

时间窗: 2 years

次要结局

  • Occurrence of unexpected adverse drug reaction after dutasteride administration(2 years)
  • Effectiveness of dutasteride judged by a physician(2 years)
  • Occurrence of serious adverse events after dutasteride administration(2 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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