NCT06568718

Efficacy and Safety of Longidaze in the Treatment of Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

A Multicenter, Randomized, Parallel, Controlled, Prospective, Open-label Study of the Efficacy and Safety of Longidaze Lyophilisate for Solution for Injections and Rectal Suppositories 3,000 IU in the Combined Treatment of Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: NPO Petrovax · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if Longidaze works to treat lower urinary tract symptoms in adult males with benign prostatic hyperplasia. It will also learn about the safety of Longidaze. The main question it aims to answer is: * Does addition of Longidaze to tamsulosin lower the severity of symptoms assessed by International Prostate Symptom Score? * What medical problems do participants have under the combined treatment by Longidaze and tamsulosin? Researchers will compare combined therapy (Longidaze + tamsulosin) with monotherapy (tamsulosin only) to see if the combination works better. Participants will: * Take tamsulosin (0.4mg) every day for 130 days * In combined therapy arm -- make intramuscular injections of Longidaze every 5 days (5 injections); then apply Longidaze rectal suppositories every 3 days (10 applications); then apply Longidaze rectal suppositories every 7 days (10 applications) * Visit the clinic on day 1, 26±1, 60±1, 130±3 for checkups and tests

Conditions

• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	bovhyaluronidase azoximer	Longidaze 3000 IU intramuscularly once every 5 days with a course of 5 injections; Longidaze 3000 IU rectal suppositories once every 3 days with a course of 10 applications; Longidaze 3000 IU rectal suppositories once every 7 days with a course of 10 applications.
DRUG	tamsulosin	Tamsulosin 0.4mg per os every day

Timeline

• Start date: 2023-03-20
• Primary completion: 2024-02-09
• Completion: 2024-02-09
• First posted: 2024-08-23
• Last updated: 2025-12-31

Locations

3 sites across 1 country: Russia