AVODART(Dutasteride) Post-marketing Surveillance(PMS)

Study Overview
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Brief Summary
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An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of AVODART administered in Korean BPH patients according to the prescribing information

Official Title
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An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVODART(Dutasteride) Administered in Korean BPH(Benign Prostatic Hyperplasia) Patients According to the Prescribing Information

Conditions
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Benign Prostatic Hyperplasia, Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Dutasteride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The Korean BPH Patients administrated dutasteride according to the prescribing information Exclusion Criteria: women and children and adolescents. patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, or any of the excipients.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dutasteride<br>Patients administrated dutasteride at the site | Drug: Dutasteride<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With an Adverse Event | An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, see the table entitled Other (Non-Serious) Adverse Events in the Adverse Event section of the results record. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Serious Adverse Event | A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record. | 6 months | 
| Number of Participants With the Indicated Unexpected Adverse Events | An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings. | 6 months |