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

Launched by EMS · Sep 14, 2021

Keywords

ClinConnect Summary

The clinical trial titled "Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation" is designed to study a new treatment for two common sexual health issues: erectile dysfunction (difficulty getting or keeping an erection) and premature ejaculation (ejaculating sooner than desired). The goal is to see how effective and safe this new treatment is for men who experience these conditions.

To participate, men must be at least 18 years old, in a stable, committed relationship for at least six months, and experiencing erectile dysfunction while being treated with specific medications. They should also have a diagnosis of premature ejaculation, meaning they ejaculate within two minutes during sexual activity. Participants will need to sign consent forms to confirm their willingness to take part in the study. It's important to note that there are certain health conditions that could prevent someone from joining, such as serious heart problems or specific neurological issues. This trial is not yet recruiting participants, but it aims to help improve treatments for men facing these challenges.

Gender

MALE

Eligibility 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.