Abstract
AIM: The present study aimed to assess the effects of Nano Leo, a prosexual nutrient formulation, on libido, erection, and orgasm in patients with erectile dysfunction (ED). METHODS: This was a prospective, single-center, phase IV efficacy study. Patients received two capsules for 7 days and thereafter one capsule through 90 days. Main outcome measures: primary endpoint was change in erectile function assessed using the International Index of Erectile Function (IIEF) questionnaire. Secondary endpoints included improvement in testosterone levels, FSH, LH, and prolactin levels; seminal parameters; and overall quality of life (QoL). RESULTS: Our study included 99 men (mean age 32.2 ± 4.71 years). Mean erectile function domain score increased from 18.9 ± 5.67 at baseline to 23.7 ± 4.01 on day 90 (P < 0.001). Similar improvements were observed in orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction domains of IIEF score which was seen as early as day 30. Improved IIEF corroborated with improvement in all QoL domains. From baseline to day 90, treatment with Nano Leo increased testosterone levels (5.04 ± 2.22 vs. 5.57 ± 1.53 ng/mL, P < 0.001). Similar improvements were observed in orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction domains of IIEF score which was seen as early as day 30. Improved IIEF corroborated with improvement in all QoL domains. From baseline to day 90, treatment with Nano Leo increased testosterone levels (5.04 ± 2.22 vs. 5.57 ± 1.53 ng/mL. CONCLUSION: Nano Leo showed improved libido, erection, and orgasm as evaluated by IIEF and QoL and was well tolerated. Therefore, Nano Leo could be an effective and safe pronutrient supplement in managing ED.