Erectile Dysfunction Clinical Trial
Official title:
National, Multicenter, Randomized, Double-blind, Double-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation
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.
Status | Not yet recruiting |
Enrollment | 232 |
Est. completion date | August 2026 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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EMS |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of participants with treatment response after 4 weeks of treatment. | The treatment response will be based on the participant's questionnaire answer after the treatment. | 4 weeks | |
Primary | Percentage of participants with treatment response after 8 weeks of treatment. | The treatment response will be based on the participant's questionnaire answer after the treatment. | 8 weeks | |
Secondary | Adverse events | Incidence and severity of adverse events recorded during the study. | 103 days |
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