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

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the efficacy and safety of Toronto association in the treatment of both sexual dysfunction: erectile dysfunction and premature ejaculation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Tadalafil

Criteria

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.