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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Erectile Dysfunction, Premature Ejaculation

Intervention / Treatment
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* Drug: Toronto association
* Drug: Tadalafil
* Other: Tadalafil placebo
* Other: Toronto association placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TORONTO 20 + 30/60<br>The study is double-dummy. The patient must take 2 tablets before the sexual intercourse, as follows: 1 tablet of Toronto association, oral; 1 tablet of tadalafil placebo, oral. | Drug: Toronto association<br>* Toronto association coated tablet, 20 mg + 30 mg or 20 mg + 60 mg, oral, 2 hours before the sexual intercourse.<br>Other: Tadalafil placebo<br>* Tadalafil placebo coated tablet, oral, 2 hours before the sexual intercourse.<br>|
| Active Comparator: TADALAFIL<br>The study is double-dummy. The patient must take 2 tablets before the sexual intercourse, as follows: 1 tablet of tadalafil , oral; 1 tablet of Toronto association placebo, oral. | Drug: Tadalafil<br>* Tadalafil coated tablet, 20 mg, oral, 2 hours before the sexual intercourse.<br>Other: Toronto association placebo<br>* Toronto association placebo coated tablet, oral, 2 hours before the sexual intercourse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Incidence and severity of adverse events recorded during the study. | 103 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile dysfunction, Premature Ejaculation