AVODART® Alopecia Post-marketing Surveillance (PMS) (AVODART®PMS)
This study is currently recruiting participants.
Verified January 2013 by GlaxoSmithKline
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01004809
First received: October 29, 2009
Last updated: February 14, 2013
Last verified: January 2013
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Purpose
Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in Korean androgenetic alopecia patients
| Condition | Intervention |
|---|---|
|
Alopecia |
Drug: Dutasteride |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
androgenetic alopecia
Drug Information available for:
Dutasteride
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of adverse event after dutasteiride administration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Occurrence of unexpected adverse events after dutasteride administration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events after dutasteride administration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 900 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Dutasteride
Patients administrated dutasteride with male hair loss
|
Drug: Dutasteride
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.
|
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| Ages Eligible for Study: | 18 Years to 41 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients administrated dutasteride with male pattern hair loss (androgenetic alopecia)
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004809
Contacts
| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Locations
| Korea, Republic of | |
| GSK Investigational Site | Recruiting |
| Daejeon, Korea, Republic of, 301-721 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01004809 History of Changes |
| Other Study ID Numbers: | 113797 |
| Study First Received: | October 29, 2009 |
| Last Updated: | February 14, 2013 |
| Health Authority: | South Korea: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Dutasteride |
Additional relevant MeSH terms:
|
Alopecia Alopecia Areata Hypotrichosis Hair Diseases Skin Diseases Pathological Conditions, Anatomical |
Dutasteride 5-alpha Reductase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013