Benign Prostate Hyperplasia Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Clinical Study to Investigate the Efficacy and Safety of Treatment With Tamsulosin 0.2mg Mono and Tamsulosin 0.2mg, Finasteride 5mg Combination Therapy in Patients With LUTS/BPH
The purpose of this study is to evaluate the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in benign prostate hyperplasia patients, and suggest guidelines of the combination therapy.
Even though it should be decided on patients cautiously under careful consideration about
prostate volume, Prostate Specific Antigen(PSA) level, symptom score and maximum uroflow,
recently the combination therapy of alpha-blocker and 5-alpha reductase inhibitor has been
tried imprudently in Korea.
As a result of several clinical trials which had conducted overseas for releasing the
combination drug of alpha-blocker and 5-alpha reductase inhibitor, the superiority of the
combination therapy has been proved, however, plenty of patients still don't derive
additional profit from it.
Therefore, in this study, the investigators anticipate to meet with meaningful results on
the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase
inhibitor combination therapy in Korean benign prostate hyperplasia patients, and provide
guidelines of the combination therapy.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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