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AVODART® Alopecia Post-marketing Surveillance (PMS)

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alopecia

Intervention: Dutasteride (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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

Clinical Details

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

Study design: Time Perspective: Prospective

Primary outcome: Occurrence of adverse event after dutasteride administration

Secondary outcome:

Occurrence of unexpected adverse drug reaction after dutasteride administration

Occurrence of serious adverse events after dutasteride administration

Effectiveness of dutasteride judged by a physician

Detailed description: 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

Eligibility

Minimum age: 18 Years. Maximum age: 41 Years. Gender(s): Male.

Criteria:

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

- Subjects who prescribed with dutasteride according to the Prescribing 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. 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.

Locations and Contacts

GSK Investigational Site, Daejeon 301-721, Korea, Republic of
Additional Information

Starting date: April 2010
Last updated: July 31, 2014

Page last updated: August 20, 2015

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