Efficacy and Safety of Longidaze in the Treatment of Lower Urinary Tract Symptoms Associated With… (NCT06568718) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of Longidaze in the Treatment of Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
Russia229 participantsStarted 2023-03-20
Plain-language 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
Who can participate
Age range40 Years
SexMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕
What they're measuring
1
Change from Baseline in IPSS Score on Day 60 and 130
. 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.
✕. 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.