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Lower Urinary Tract SymptomsADAMNCT06568718

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

A study testing bovhyaluronidase azoximer and tamsulosin in people with Lower Urinary Tract Symptoms and Prostatic Hyperplasia, run by NPO Petrovax at 3 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older, men only
What is being tested?
bovhyaluronidase azoximer and tamsulosin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
229 participants
Where
3 sitesRussia
Study dates
20 Mar 2023to 9 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Written Informed Consent Form for participation in the study.
  • Male outpatients aged 40 years or older.
  • Presence of lower urinary tract symptoms due to BPH at least 6 months prior to the screening visit.
  • Symptom severity according to the International Prostate Symptom Score (IPSS) ≥ 8 at the screening visit.
  • Negative urethral smear (PCR) test for chlamydia, gonorrhea, trichomoniasis, mycoplasmosis and ureaplasmosis performed no earlier than 1 month prior to study inclusion.
  • Negative blood test (ELISA) for syphilis performed no earlier than 1 month prior to study inclusion.
  • Maximum urine flow rate (Qmax) based on uroflowmetry results during screening is ≥5 ml/sec; residual urine volume during screening is up to 150 ml.
  • Consent to follow the effective methods of contraception specified in the protocol throughout the study.

Who cannot join

  • History of hypersensitivity to the study drug, background therapy drug or their components or intolerance thereof.
  • Patients who require or do not wish to stop taking drugs prohibited before or during the study.
  • Contraindications to the study therapy at the time of screening: acute infectious diseases; pulmonary hemorrhage and hemoptysis; fresh vitreous hemorrhage.
  • Hematuria, hematological diseases, oncological diseases, chronic heart failure class III-IV according to the New York Heart Association system, diabetes mellitus, chronic renal failure, hypogonadism in the history.
  • Acute prostatitis at the time of screening and/or within 4 weeks before screening.
  • Symptoms of urinary tract infection at the time of screening and/or within 4 weeks before the screening visit.
Show all 29Show fewer
  • Need for planned surgical treatment of BPH and/or any other concomitant disease within 5 months from the screening visit.
  • History of prostatectomy, transurethral resection and/or other surgical interventions on the prostate gland, bladder or pelvic organs.
  • Neurogenic dysfunction of the bladder, congenital anomalies of the genitourinary system, sclerosis of the bladder neck, bladder diverticula, urolithiasis, bladder cancer or other bladder diseases in the medical history.
  • History of urethral stricture.
  • History of spinal injury.
  • Prostate-specific antigen (PSA) level \>4 ng/ml at the screening visit or according to laboratory tests performed no more than 4 weeks before inclusion in the study.
  • History of acute urinary retention.
  • Use of any antibacterial drugs (except topical drugs) within 2 months before the screening visit.
  • Use of any medications for the treatment of LUTS/BPH before the study, including herbal preparations containing extracts of Serenoa repens and Pygeum Africanum.
  • History of orthostatic hypotension.
  • Patients with significant liver dysfunction at the screening visit: total bilirubin \>2 ULN, albumin \<35 g/L, prothrombin time \>3 ULN.
  • Patients with significant renal dysfunction at the screening visit (blood creatinine \>2 ULN), and / or patients on dialysis and / or patients with a history of kidney transplant.
  • The patient is scheduled for cataract or glaucoma surgery within 5 months after screening.
  • The presence of sexually transmitted diseases at the time of screening.
  • Patients with positive blood test results for HIV and/or hepatitis B and/or hepatitis C, performed no earlier than 1 month before the screening visit, or at the screening.
  • Decompensated diabetes mellitus (blood glucose and/or HbAc1 grade 3 or higher according to the used CTCAE 4.03 classifier);
  • Severe CNS diseases, including a history of seizures or conditions that may lead to their development; stroke or transient ischemic attack within 12 months before screening; traumatic brain injury or cases of loss of consciousness within 12 months before screening; brain tumor
  • Patients with mental disorders such as psychosis, manic-depressive disorders, chronic depression.
  • Acute or chronic gastric and/or duodenal ulcer at the time of screening.
  • History of alcoholism, drug addiction, drug abuse.
  • Participation in other interventional clinical trials of drugs less than 90 days before the screening visit.
  • Any conditions that, in the opinion of the Investigator, may interfere with the patients participation in the study, compliance with the procedures, or be contrary to his interests, as well as affect the results of the study.
  • Employees of the study center or the Sponsor company, their family members or subjects in dependent relationships.

Trial locations and contacts

3 sites in 1 country.

Russia3 sites

  • LLC "Krasnodar Medical and Biological Center"

    Krasnodar, 350000

  • First Saint Petersburg State Medical University named after academician I.P. Pavlov

    Saint Petersburg, 197022

  • LLC "Clinic of Modern Medicine of Dr. Bogorodskaya"

    Yaroslavl, 150001

Other trials in Russia

About this study

Official title: 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

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?
Read more

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
Being tested
bovhyaluronidase azoximer, tamsulosin
Medical subject headings
Lower Urinary Tract Symptoms, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bovhyaluronidase azoximerDrug

    Also called Longidaze

    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.

  • tamsulosinDrug

    Tamsulosin 0.4mg per os every day

Study groups in NCT06568718
Study groupRoleWhat they receive
Longidaze + TamsulosinExperimentalNot described
Receives: Drug: bovhyaluronidase azoximer; Drug: tamsulosin
TamsulosinActive comparatorNot described
Receives: Drug: tamsulosin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in IPSS Score on Day 60 and 130

    Change in symptom severity assessed by the patient using the International Prostate Symptom Score (IPSS) relative to baseline on days 60 and 130 of therapy. IPSS score ranges from 0 to 35 with higher score representing more severe symptoms.

    Measured: Day 0, Day 60, Day 130

Secondary outcomes (9)

  1. Change from Baseline in IPSS Score on Day 26

    Change in symptom severity assessed by the patient using the International Prostate Symptom Score (IPSS) relative to baseline on day 26 of therapy. IPSS score ranges from 0 to 35 with higher score representing more severe symptoms.

    Measured: Day 0, Day 26

  2. Change from Baseline in Qmax

    Change in maximum urine flow rate (Qmax) according to uroflowmetry relative to baseline

    Measured: Day 0, Day 26, Day 60, Day 130

  3. Change from Baseline in Prostate Volume

    Change in prostate volume relative to baseline

    Measured: Day 0, Day 26, Day 60, Day 130

  4. Number of Participants with 4 Points and/or 25% Decrease in IPSS Score

    Proportion of patients showing a decrease in symptom severity as assessed by the IPSS questionnaire by 4 or more points and/or by 25% from the baseline.

    Measured: Day 0, Day 26, Day 60, Day 130

  5. Change from Baseline in IPSS QoL Score

    Change in quality of life (QoL) assessed by the patient using the International Prostate Symptom Score (IPSS, QoL domain) relative to baseline. IPSS QoL score ranges from 0 ("delighted") to 6 ("terrible").

    Measured: Day 0, Day 26, Day 60, Day 130

  6. Change from Baseline in IPSS-V Score

    Change in voiding symptom severity assessed by the patient using the IPSS questionnaire (IPSS-V subscore) relative to baseline. IPSS-V score ranges from 0 to 20 with higher score representing more severe symptoms.

    Measured: Day 0, Day 26, Day 60, Day 130

  7. Change from Baseline in IPSS-S Score

    Change in storage symptom severity assessed by the patient using the IPSS questionnaire (IPSS-S subscore) relative to baseline. IPSS-S score ranges from 0 to 15 with higher score representing more severe symptoms.

    Measured: Day 0, Day 26, Day 60, Day 130

  8. Change from Baseline in Residual Urine Volume

    Change in residual urine volume based on ultrasound data relative to baseline

    Measured: Day 0, Day 26, Day 60, Day 130

  9. Change from Baseline in NIH-CPSI Score

    Change in symptom severity according to the NIH Chronic Prostatitis Symptom index (NIH-CPSI) questionnaire relative to the baseline

    Measured: Day 0, Day 26, Day 60, Day 130

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2024
  2. Study start20 Mar 2023
  3. Primary completion9 Feb 2024
  4. Study completion9 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06568718
Sponsor's protocol ID
LG-ADAM-23
Acronym
ADAM
Status last verified
Aug 2024
First submitted
21 Aug 2024
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing bovhyaluronidase azoximer and tamsulosin in people with Lower Urinary Tract Symptoms and Prostatic Hyperplasia, run by NPO Petrovax at 3 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in IPSS Score on Day 60 and 130 (time frame: Day 0, Day 60, Day 130). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06568718.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.

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