Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation

Inclusion Criteria: * Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * Male participants, with age greater than or equal to 18 years; * Heterosexual, sexually active participants in a stable and monogamous relationship for at least 6 months before screening and who plan to maintain this relationship throughout the study period; * Participants with erectile dysfunction, in stable and effective treatment with PDE-5 inhibitors; * Participants diagnosed with premature ejaculation; * Participants with IELT ≤ 2 minutes; * Participants with score ≥ 25 points in the erectile function questionnaire; * Participants (or partners) who use at least one contraceptive method. Exclusion Criteria: * Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; * Participation in a clinical trial in the year prior to this study; * Known hypersensitivity to any of the formula compounds; * Participants with cardiovascular disease for whom sexual activity is inadvisable * History or current experience of surgical interventions or radiotherapy in the pelvic region, neurological conditions, trauma or infections that are associated with the symptoms premature ejaculation; * Diagnosis of other diseases or conditions in the urinary tract; * Participants with conditions that may predispose them to priapism; * History of severe psychiatric or psychosocial disorders; * Participant whose partner has clinically important sexual dysfunctions.