AVODART� Alopecia Post-marketing Surveillance (PMS)
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alopecia
Intervention: Dutasteride (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
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 dutasteiride administration
Secondary outcome: Occurrence of unexpected adverse events after dutasteride administrationOccurrence of serious adverse events after dutasteride administration
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 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
Locations and Contacts
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
GSK Investigational Site, Daejeon 301-721, Korea, Republic of; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
Additional Information
Starting date: April 2010
Last updated: January 21, 2013
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