Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Toronto association, Tadalafil, Tadalafil placebo, Toronto association placebo.
- Who it may be relevant to
- Registry conditions: Erectile Dysfunction, Premature Ejaculation. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Toronto association
Toronto association coated tablet, 20 mg + 30 mg or 20 mg + 60 mg, oral, 2 hours before the sexual intercourse. - Drug Tadalafil
Tadalafil coated tablet, 20 mg, oral, 2 hours before the sexual intercourse. - Other Tadalafil placebo
Tadalafil placebo coated tablet, oral, 2 hours before the sexual intercourse. - Other Toronto association placebo
Toronto association placebo coated tablet, oral, 2 hours before the sexual intercourse.
Primary outcome measures
- Percentage of participants with treatment response after 4 weeks of treatment. [Time frame: 4 weeks]
- Percentage of participants with treatment response after 8 weeks of treatment. [Time frame: 8 weeks]
Secondary outcome measures (1)
- Adverse events [Time frame: 103 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05052879 · EMS0220 - TORONTO