AVODART® Alopecia Post-marketing Surveillance (PMS)

Completed

• Conditions: Alopecia
• Interventions: Drug: Dutasteride

• Registration Number: NCT01004809
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Study Start: 2010-04-29
• Primary Completion: 2012-12-01
• Study Completion: 2012-12-21
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 712

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dutasteride	Dutasteride	Patients administrated dutasteride with male hair loss

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse event after dutasteride administration	2 years

Secondary Outcome Measures

Name	Time	Method
Effectiveness of dutasteride judged by a physician	2 years
Occurrence of serious adverse events after dutasteride administration	2 years
Occurrence of unexpected adverse drug reaction after dutasteride administration	2 years

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Daejeon, Korea, Republic of