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

> **NCT06546735** · PHASE3 · NOT_YET_RECRUITING · sponsor: **Eurofarma Laboratorios S.A.** · enrollment: 816 (estimated)

## Conditions studied

- Benign Prostatic Hyperplasia with Lower Urinary Tract Symptoms

## Interventions

- **DRUG:** N0728
- **DRUG:** Vesomni®

## Key facts

- **NCT ID:** NCT06546735
- **Lead sponsor:** Eurofarma Laboratorios S.A.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-11-30
- **Primary completion:** 2028-04-30
- **Final completion:** 2028-08-30
- **Target enrollment:** 816 (ESTIMATED)
- **Last updated:** 2024-11-15


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06546735

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06546735, "Efficacy and Safety of Two Fixed-dose Combinations in Men with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia. (BENIPRO)". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT06546735. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*