Phase 2 Efficacy Study of Sildenafil Products in Adult Men With Erectile Dysfunction

Inclusion Criteria: * Male, 18 to 70 years of age. Documented diagnosis of erectile dysfunction (ED) for at least 3 months, confirmed by a clinician. Baseline International Index of Erectile Function-Erectile Function (IIEF-EF) domain score ≤25. Sexually active and attempting sexual intercourse at least 4 times per month during the 3 months prior to screening. Willing and able to attempt sexual intercourse at least once per week during the study. Judged by the Investigator to be in good general health other than ED. Creatinine clearance (CrCl) \>80 mL/min as calculated by Cockcroft-Gault. Able and willing to comply with all study procedures, including use of eDiary/ePRO tools and adherence to dosing instructions. Exclusion Criteria: * Use of nitrates or nitric oxide donors in any form. Use of prohibited antihypertensive medications as defined in the protocol. Use of phosphodiesterase type 5 (PDE5) inhibitors within 5 days prior to baseline. Use of CYP450 inhibitors within 14 days prior to first dose. Use of CYP450 inducers or St. John's Wort within 28 days prior to first dose. Use of any prescription or non-prescription medications, herbal products, or dietary supplements not approved by the Investigator during the required restriction period. Known hypersensitivity to sildenafil, tadalafil, vardenafil, peppermint oil, or any component of the investigational product. Clinically significant abnormalities in screening laboratory tests, vital signs, or electroca…