N/A
Completed N=3,977
AVODART(Dutasteride) Post-marketing Surveillance(PMS)
Benign Prostatic Hyperplasia · Prostatic Hyperplasia
Source: ClinicalTrials.gov NCT01299571 ↗
Enrolled (actual)
3,977
Serious AEs
0.1%
Results posted
Apr 2011
Primary outcomePrimary: Number of Participants With an Adverse Event — 146 participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Adverse Event |
146 | — |
| SECONDARY Number of Participants With a Serious Adverse Event |
5 | — |
| SECONDARY Number of Participants With the Indicated Unexpected Adverse Events |
2; 3; 2; 2; 2; 1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01299571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.