AVODART® Alopecia Post-marketing Surveillance (PMS)

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”

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

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

Intervention(s) in this Clinical Trial

• Drug: Dutasteride
  • Basically there is no treatment allocation. Subjects who would be administered of dutasteride 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

• : Dutasteride
  • Patients administrated dutasteride with male hair loss

Primary Measures

• Occurrence of adverse event after dutasteiride administration
  • Time Frame: 2 years
    Safety Issue?: No

Secondary Measures

• Occurrence of unexpected adverse events after dutasteride administration
  • Time Frame: 2 years
    Safety Issue?: No
• Occurrence of serious adverse events after dutasteride administration
  • Time Frame: 2 years
    Safety Issue?: No

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 dutasteride 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 Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials Study Director GlaxoSmithKline  

Overall Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Information obtained from ClinicalTrials.gov on February 09, 2012

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