Official Title: “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”

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

Study Type: Observational

Study Design: Other, Prospective

Study Primary Completion Date: July 2013

Intervention(s) in this Clinical Trial

• Drug: AVODAR®
  • Basically there is no treatment allocation. Subjects who would be administered of AVODAR® at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

Arms, Groups and Cohorts in this Clinical Trial

• : AVODART®
  • Patients administrated AVODAR® at the site

Primary Measures

• Occurrence of adverse event after AVODAR® administration
  • Time Frame: 2 years
    Safety Issue?: Yes

Secondary Measures

• Effectiveness after AVODAR® administration
  • Time Frame: 2 years
    Safety Issue?: No
• Occurrence of unexpected or serious adverse event after AVODAR® administration
  • Time Frame: 2 years
    Safety Issue?: Yes

Inclusion Criteria:

• 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 and follow the administration regimen
• Subjects who provide informed consent for providing their medical information.

Exclusion Criteria:

• Considering the nature of observational study, GSK Korea encourages the doctors participating in this study to enrol the subjects prescribed with AVODART® following the locally approved Prescribing Information

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 41 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials Study Director GlaxoSmithKline  

Overall Contact: US GSK Clinical Trials Call Center 877-379-3718 

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01004809

Study ID Number: 113797

ClinicalTrials.gov Identifier: NCT01004809

Health Authority: South Korea: Food and Drug Administration