MedTrace Logo

Treatment of BPH With CO2 Serenoa +PEA as Monotherapy or in Combination With Tamsulosin: ProSeRePEA Trial

NCT06181175 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2023-12-26

No results posted yet for this study

Summary

The objective of this study is to evaluate the efficacy of the supplement PEAPROSTIL 600 (FARMITALIA®) composed of Serenoa Repens combined with PEA in single or combined therapy with alpha-blocker in the reduction of voiding symptoms in benign prostatic hyperplasia (BPH) patients at low risk of progression to obstructing conditioning that need for surgical therapy. Any adverse events, intolerance, allergic reactions, complications related to the products used will be recorded throughout the study period.

Conditions

  • Benign Prostatic Hyperplasia
  • Urinary Obstruction
  • Lower Urinary Tract Symptoms

Interventions

DRUG

PEAPROSTIL 600 + Tamsulosin 0.4 mg

PEAPROSTIL 600 mg one sachet oral daily+ Tamsulosin 0.4 mg one tablet oral daily

DRUG

Tamsulosin 0.4 mg

Tamsulosin 0.4 mg one tablet oral daily

DRUG

PEAPROSTIL 600 mg

PEAPROSTIL 600 mg one sachet oral daily

Sponsors & Collaborators

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    lead OTHER

Principal Investigators

  • Michele Billia, MD · SCDU Urologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-10-30
Completion
2025-04-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06181175 on ClinicalTrials.gov