Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression
Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression
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.
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.