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 administrationOccurrence 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
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