Introduction. Erectile dysfunction (ED) occurs in more than half of men over 40 years of age, occupying a leading place in the sexual disorders structure. Herbal remedies can be used for initial treatment of ED. ED and testosterone deficiency syndrome are closely interrelated and when correcting these conditions, the specific treatment of both should be taken into account.
Aim: to evaluate serum total testosterone level changes in patients with ED during routine use of EFFEX® Tribulus (Evalar, Russia).
Materials and methods. This multicenter, open-label, non-interventional prospective study included men 30-55 years of age who were prescribed EFFEX® Tribulus (Evalar, Russia) at a standard dosage for mild to moderate ED. Patients were excluded if ED due to organic causes. The total observation period was 84±6 days with three visits. The effect of EFFEX® Tribulus (Evalar, Russia) on serum total testosterone was studied. In addition, its impact on erectile function was evaluated by IIEF, AMS (Aging Males’ Symptoms scale) и GAQ (Global Assessment Question). All adverse events (AEs) was collected during treatment for safety assessment.
Results. The study included 100 men with ED, aged 41.7±6.01, without comorbidities. Over 3 months of treatment, serum total testosterone levels increased from 11.06±4.79 ng/dL (log 2.31±0.46) at Visit 1 to 12.58±5.48 ng/dL (2.44±0.45) at Visit 3 (p <0.001). Significant improvements were recorded according to IIEF, AMS, and GAQ (p <0.05) by Visit 3. No AEs were identified during the study. These results are similar with recent meta-analyses of standardized Tribulus terrestris-based drugs clinical efficacy and safety.
Conclusion. In this non-interventional study of EFFEX® Tribulus (Evalar, Russia) patients with ED achieved statistically significant improvements in hormonal level and erectile function after 3 months of treatment.
