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

PHASE3CompletedINTERVENTIONAL
Enrollment

667

Participants

Timeline

Start Date

July 27, 2021

Primary Completion Date

June 12, 2023

Study Completion Date

June 12, 2023

Conditions
Benign Prostatic Hyperplasia
Interventions
DRUG

DKF-313

Combination of dutasteride 0.5 mg and tadalafil 5 mg once daily for 48 weeks

DRUG

Dutasteride

Dutasteride 0.5 mg once daily for 48 weeks

DRUG

Tadalafil

Tadalafil 5 mg once daily for 48 weeks

DRUG

DKF-313 placebo

Once daily for 48 weeks

DRUG

Dutasteride placebo

Once daily for 48 weeks

DRUG

Tadalafil placebo

Once daily for 48 weeks

Trial Locations (1)

Unknown

Ewha Womans University mokdong Hospital, Seoul

All Listed Sponsors
lead

Dongkook Pharmaceutical Co., Ltd.

INDUSTRY