AN OPEN LABEL, INTERVENTIONAL, MULTI-CENTER, PROSPECTIVE CLINICAL STUDY TO EVALUATE EFFICACY AND SAFETY OF „AYUVIGO FORTE CAPSULE? IN PATIENTS SUFFERING FROM MILD TO MODERATE ERECTILE DYSFUNCTION

Narendra Mundhe, V.E. Gogate, Vijay Ukhalkar, Tejal Bhatia and *Sanjay M. Tamoli

ABSTRACT

Objectives: The main objective of the study was to evaluate the efficacy and safety of „Ayuvigo Forte‟ capsule in subjects suffering from mild to moderate erectile dysfunction (ED). Methods: It was an open label, interventional, multi-center, prospective, phase II clinical trial. Study was completed in 31 subjects. All the subjects were advised to take two Ayuvigo Forte capsules thrice daily orally after meals with water for 30 days. After screening visit (day -3), all the subjects were called for baseline visit (day 0) and follow-up on day 15 and day 30. Data describing quantitative measures were expressed as mean + SD. Results: At the end of the treatment, IIEF questionnaire showed significant improvement in erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction domains. Evaluation of male sexual health on EDITS questionnaire (patient & partner version) and quality of sexual life on SQoL questionnaire showed a significant improvement at the end of the study period. Global evaluation by the physician and patient showed excellent response to the study treatment. Almost all patients showed excellent tolerability to the study drug. No significant change in vital parameters and safety laboratory parameters were observed at the end of the study. Conclusion: The study provides good evidence in support of the efficacy and safety of Ayuvigo Forte capsule in loss of libido and mild to moderate cases of erectile dysfunction.

Keywords: Ayuvigo Forte capsule, IIEF questionnaire, EDITS questionnaire, SQoL questionnaire.