Evaluation of efficacy and safety of the AHPL/AYCAP/0114 capsule in subjects suffering from erectile dysfunction

Abstract

Abstract Background and Objectives: Oral phosphodiesterase type 5 (PDE5) inhibitors facilitate erections, however, unable to restore sexual desire (SD), overcome sexual resistance, or treat relational discord. The current investigation aimed to assess the safety and effectiveness of the AHPL/AYCAP/0114 capsule in subjects experiencing erectile dysfunction (ED). Materials and Methods: The study design employed a noncomparative, interventional, open-label format. It was conducted at a single center and followed a prospective clinical methodology. A total of 46 patients completed the study. Patients were asked to take two AHPL/AYCAP/0114 capsules two times a day orally after meals with milk for 90 days. Changes in all domain scores of the International Index of Erectile Function questionnaire, hardness of penis, male sexual health, sexual encounter profile, overall improvement, serum total testosterone, AE, and lab parameters were outcomes of the study. Statistical analysis involved the application of the chi-square test, Wilcoxon signed-rank test, and Student t test to examine the relevant data. Results: On day 90, there was a notable and statistically significant increase in the mean Erectile Function Domain Score, with a rise of 42.4%. Significant improvements were observed on day 90 across multiple domains, including mean orgasmic function, mean SD, mean intercourse satisfaction, and mean sexual satisfaction domain scores. On day 90, complete improvement with full penile rigidity was observed in 78.3% of subjects, whereas 67.4% of subjects were very satisfied with the treatment and their sexual health and 78% of subjects showed good to excellent improvement. Serum total testosterone increased significantly by 1.29 times. Following the treatment, there were no significant changes observed in any of the laboratory parameters, indicating the safety of the AHPL/AYCAP/0114 capsule. Interpretation and Conclusions: The AHPL/AYCAP/0114 capsule was found to be safe and effective for the treatment of ED.