Arthur M Kummer, MD

CONTACT

Lead Sponsor

EMS

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

No

•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.

•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.