Study of Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Medicinal Product MediReg®

Exclusion Criteria

• •1\. Age younger than 21 and older than 60 years at the time of inclusion in the study.
• •2\. developmental anomalies of the genitourinary system (according to bladder and kidney ultrasound).
• •3\. surgical interventions on genitourinary organs in the history, except for surgical interventions associated with assisted reproductive technologies. 4.
• •4\. Systemic diseases requiring administration of corticosteroids, cytostatics, radiation therapy.
• •5\. Inflammatory diseases of the urinary and/or reproductive system. 6. Infectious diseases (including STDs) of the urinary and/or reproductive system.
• •7\. Hereditary factors of infertility: (Klinefelter syndrome (all variants), autosomal abnormalities (all variants), carrying the cystic fibrosis gene (all variants), presence of Y-chromosome microdeletions (all AZF variants), autosomal defects with severe phenotypic abnormalities and infertility (Prader-Willi, Bardet-Biedl, Noonan syndromes, myotonic dystrophy, dominant polycystic kidney disease, 5-alpha-reductase enzyme deficiency, etc.). д.).
• •8\. Obstructive azoospermia by history or established by screening examination. 9. Positive test for HIV, hepatitis B and C, syphilis. 10. Severe liver failure or active liver disease (transaminase activity exceeding 5 times the upper limit of the local laboratory norm).
• •11\. Renal dysfunction with serum creatinine levels exceeding 120 µmol/L. 12. Cardiovascular diseases in the history within 6 months before inclusion in the study, such as myocardial infarction, angina pectoris, severe ventricular arrhythmia, heart failure (NYHA class II-IV).
• •13\. Neurologic (Parkinson's disease) and/or psychiatric illnesses with a history or established by screening examination.
• •14\. Cancer with a history of cancer or as determined by screening examination (as determined by OBP and renal ultrasound, bladder ultrasound, prostate TRUS).
• •15\. Hypersensitivity to any of the components of the study drug in the history. 16. Mental illness, severe cognitive impairment, need to take tranquilizers, neuroleptics and/or antidepressants during this study.
• •17\. Severe somatic illnesses that, in the opinion of the investigator, may affect the patient's safety and ability to comply with the Protocol.
• •18\. A history of drug dependence. 19. Positive urinalysis for psychotropic and narcotic drugs, psychoactive medications.
• •20\. Intake of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to 1⁄2 liter of beer, 200 ml of wine, or 50 ml of alcohol) or a history of alcoholism.
• •21\. Detection of alcohol vapor in breath 22. Participation in another clinical trial currently or in the previous 30 days prior to the screening visit.
• •23\. Patient's inability to understand or comply with study procedures or patient's refusal to cooperate with a particular investigator