Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Afalaza; Placebo
Intervention description: Safety and Efficacy; Safety and Efficacy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 260.0
Sex: Male
Minimum age: 45 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this study is:

        -  To assess safety of Afalaza drug within 12 months in patients with symptoms of benign
           prostatic hyperplasia (BPH) and risk of progression.

        -  To assess efficacy of Afalaza drug within 12 months in patients with symptoms of benign
           prostatic hyperplasia and risk of progression.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male patients 45 to 60 y.o. inclusive with a documented diagnosis of Benign prostatic
             hyperplasia.

          2. Lower urinary tract symptoms (LUTS) having been experienced for 3 months and longer.

          3. Total IPSS score (International Prostate Symptome Score) of 8 to 15.

          4. Prostate volume of more than 30 cm3.

          5. Maximal urinary flow rate of 10-15 mL/sec.

          6. Micturition volume of 125-350 mL.

          7. Residual volume of less than 100 mL.

          8. Serum prostate-specific antigen (PSA) level of less than 4 ng/mL.

          9. Use of and compliance with contraceptive methods during the trial and for 30 days upon
             completion of participation in the trial.

         10. Presence of the patient's information sheet (informed consent form) for participation
             in the clinical trial.

        Exclusion Criteria:

          1. Invasive therapies for BPH including a transurethral prostatic resection,
             thermotherapy, microwave therapy, transurethral needle ablation, stenting, etc.

          2. Malignant oncological disease of the urogenital system as well as malignancies of any
             other localization during last 5 years.

          3. Acute urinary retention (AUR) within 3 months before inclusion in the trial.

          4. Neurogenic dysfunctions and bladder ears.

          5. Urinary stone disease.

          6. Urethral stricture, bladder neck sclerosis.

          7. History of operative aids for pelvic organs.

          8. Urogenital infections in the phase of active inflammation.

          9. Systematic administration of agents exhibiting effects on bladder function and urine
             production.

         10. Exacerbation or decompensation of chronic diseases affecting the possibility of
             patients to participate in the clinical trial, including severe concurrent
             cardiovascular conditions and disorders of the nervous system, renal and hepatic
             insufficiency.

         11. History of administration of testosterone 5-alpha-reductase inhibitors (finasteride,
             dutasteride).

         12. History of polyvalent allergy.

         13. Allergy/intolerance to any component of drug agents used in the therapy.

         14. Malabsorption syndrome, including congenital or acquired lactase or other
             disaccharidase deficiency.

         15. Administration of drugs specified as "Prohibited concomitant therapy", within 3 months
             before enrollment.

         16. Exacerbation or decompensation of chronic diseases affecting the possibility of
             patients to participate in the clinical trial.

         17. Drug and alcohol consumption (over 2 alc. units daily), mental diseases. Legal
             incapacity or limited legal capacity.

         18. Legal incapacitation or limited legal capacity.

         19. Patients, who, in the investigator's opinion, will fail to observe the requirements
             during the trial or adhere to the studied drug administration procedure.

         20. Participation in other clinical trials within 3 months before enrolment in this trial.

         21. Presence of other factors, complicating the patient's participation in the trial
             (e.g., planned lengthy business and other trips).

         22. A patient is a part of the center's research staff, taking a direct part in the trial,
             or an immediate family member of the investigator. Immediate family members are
             defined as spouses, parents, children or siblings, regardless of whether full blood or
             adopted.

         23. The patient is employed with Scientific Production Firm Materia Medica Holding LLC,
             i.e. is the company's employee, part-time employee under contract, or appointed
             official in charge of the trial, or their immediate family.