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NCT01004809 Clinical Trial

AVODART® Alopecia Post-marketing Surveillance (PMS)

Alopecia Clinical Trial

— AVODART®PMS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01004809
Other study ID # 113797
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 29, 2010
Est. completion date December 21, 2012

Study information
Verified date June 2018
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 712
Est. completion date December 21, 2012
Est. primary completion date December 1, 2012
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 41 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Korea, Republic of GSK Investigational Site Daejeon

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of adverse event after dutasteride administration 2 years
Secondary Occurrence of unexpected adverse drug reaction after dutasteride administration 2 years
Secondary Occurrence of serious adverse events after dutasteride administration 2 years
Secondary Effectiveness of dutasteride judged by a physician 2 years
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