RESUMO
OBJECTIVE: Evaluation of the effectiveness and safety of the drug PPR-001 (lyophilizate) in comparison with placebo in men with impaired spermatogenesis. MATERIALS AND METHODS: This study was a randomized, double-blind, placebo-controlled, prospective, multicenter, parallel-group research. RESULTS: It was found that the drug has clinical efficacy and a positive effect on the concentration of spermatozoa in the ejaculate, the percentage of progressively mobile forms and the number of morphologically normal forms of spermatozoa was increased in the group of PPR-001. The primary end point was defined as a proportion of patients who had a therapeutic response (TO) at Visit 3. TO meant at least 20% increase in the concentration and/or progressive motility of spermatozoa compared to the baseline level. The hypothesis of Superiority of PPR-001 over placebo based on primary end point was confirmed (the limit of Superiority was more than 27%). In total, AEs were identified in 65 patients out of 100 (34 patients in the PPR-001 group and 31 patients in the placebo group). When assessing the number of patients who had AEs, there were no statistically significant differences between the groups. All identified AEs were of mild severity; during the study. No negative dynamics was found according to the results of the assessment of vital functions, biochemical and clinical blood tests, clinical urinalysis, ECG indicators. CONCLUSION: The study demonstrated the superiority of PPR-001 over placebo in terms of increasing concentration and motility of spermatozoa in the ejaculate. A significant increase in the number of morphologically normal forms of spermatozoa in the PPR-001 group was also revealed.