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

• Status: COMPLETED
• Trial end date: 2024-02-09

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

• Phase: NA

Details

• Lead Sponsor: NPO Petrovax
• Treatments: Tamsulosin