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.