AVODART® Alopecia Post-marketing Surveillance (PMS)

GlaxoSmithKline712 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

712

Conditions

Alopecia

Interventions

DutasterideDRUG

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

Sex: MALEMin age: 18 YearsMax age: 41 Years

Medical Language ↔ Plain English

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 (1)

GSK Investigational Site

Daejeon, South Korea

Outcomes

Primary Outcomes

Occurrence of adverse event after dutasteride administration

Time frame: 2 years

Secondary Outcomes

Occurrence of unexpected adverse drug reaction after dutasteride administration

Time frame: 2 years

Occurrence of serious adverse events after dutasteride administration

Time frame: 2 years

Effectiveness of dutasteride judged by a physician

Time frame: 2 years

Data from ClinicalTrials.gov

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