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

NCT06568718 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 229

Last updated 2025-12-31

No results posted yet for this study

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

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

Sponsors & Collaborators

  • NPO Petrovax

    lead INDUSTRY

Principal Investigators

  • Pavel I. Rasner · University Clinic of the Scientific and Educational Institute of Clinical Medicine named after N.A. Semashko

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2024-02-09
Completion
2024-02-09

Countries

  • Russia

Study Locations

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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 NCT06568718 on ClinicalTrials.gov