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Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia Clinical Trial

Official title:
A Multi-center, Randomized, Double-blinded, Double-dummy, Parallel Group, 48-week, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia

Clinical Trial Summary

This is a multi-center, randomized, double-blinded, double-dummy, parallel group, 48-week study to evaluated the efficacy and safety of DKF-313 (dutasteride and tadalafil) in patients with benign prostatic hyperplasia.

Clinical Trial Description

This study is conducted to access whether DKF-313 once daily for 48 weeks is superior to dutasteride 0.5 mg once daily and tadalafil 5 mg once daily each in improving BPH-LUTS as measured by changes in IPSS total scores. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04947631
Study type Interventional
Source Dongkook Pharmaceutical Co., Ltd.
Contact
Status Completed
Phase Phase 3
Start date July 27, 2021
Completion date June 12, 2023
View Details
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