Efficacy and Safety of Two Fixed-dose Combinations in Men with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia. (BENIPRO)

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

816

Participants

Timeline

Start Date

November 30, 2026

Primary Completion Date

April 30, 2028

Study Completion Date

August 30, 2028

Conditions
Benign Prostatic Hyperplasia with Lower Urinary Tract Symptoms
Interventions
DRUG

N0728

1 tablet of the test drug (N0728) and 1 tablet of placebo of Vesomni®.

DRUG

Vesomni®

1 tablet of the comparator drug Vesomni® and 1 tablet of the placebo of the test drug.

Trial Locations (1)

06696-00

Eurofarma Laboratorios S.A, São Paulo

Sponsors
All Listed Sponsors
lead

Eurofarma Laboratorios S.A.

INDUSTRY