NCT01736033

Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 545 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Benign Prostate Hyperplasia

Interventions

Type	Name	Description
DRUG	Tamsulosin	1 tablet(0.2mg) orally q.d.
DRUG	Finasteride	1 tablet(5mg) orally q.d.
DRUG	Placebo	1 tablet(0.2mg) orally q.d.

Timeline

• Start date: 2012-02-01
• Primary completion: 2017-02-01
• Completion: 2017-06-01
• First posted: 2012-11-29
• Last updated: 2014-05-14

Locations

11 sites across 1 country: South Korea