AVODART® Alopecia Post-marketing Surveillance (PMS)
AVODART®PMS
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
1 other identifier
observational
712
1 country
1
Brief Summary
Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in Korean androgenetic alopecia patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2009
CompletedFirst Posted
Study publicly available on registry
October 30, 2009
CompletedStudy Start
First participant enrolled
April 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2012
CompletedJune 19, 2018
June 1, 2018
2.6 years
October 29, 2009
June 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of adverse event after dutasteride administration
2 years
Secondary Outcomes (3)
Occurrence of unexpected adverse drug reaction after dutasteride administration
2 years
Occurrence of serious adverse events after dutasteride administration
2 years
Effectiveness of dutasteride judged by a physician
2 years
Study Arms (1)
Dutasteride
Patients administrated dutasteride with male hair loss
Interventions
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.
Eligibility Criteria
Patients administrated dutasteride with male pattern hair loss (androgenetic alopecia)
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Daejeon, 301-721, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2009
First Posted
October 30, 2009
Study Start
April 29, 2010
Primary Completion
December 1, 2012
Study Completion
December 21, 2012
Last Updated
June 19, 2018
Record last verified: 2018-06