Erectile DysfunctionPhase 3NCT05052879
Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation
A Phase 3 study testing Toronto association and Tadalafil in people with Erectile Dysfunction and Premature Ejaculation, run by EMS.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction, Premature Ejaculation
- What is being tested?
- Toronto association and Tadalafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Participants with conditions that may predispose them to priapism;
- History of severe psychiatric or psychosocial disorders;
- Participant whose partner has clinically important sexual dysfunctions.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Erectile Dysfunction, Premature Ejaculation
- Being tested
- Toronto association, Tadalafil, Tadalafil placebo, Toronto association placebo
- Keywords
- Erectile dysfunction, Premature Ejaculation
- Medical subject headings
- Erectile Dysfunction, Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toronto associationDrug
Toronto association coated tablet, 20 mg + 30 mg or 20 mg + 60 mg, oral, 2 hours before the sexual intercourse.
TadalafilDrug
Tadalafil coated tablet, 20 mg, oral, 2 hours before the sexual intercourse.
Tadalafil placeboOther
Tadalafil placebo coated tablet, oral, 2 hours before the sexual intercourse.
Toronto association placeboOther
Toronto association placebo coated tablet, oral, 2 hours before the sexual intercourse.
| Study group | Role | What they receive |
|---|---|---|
| TORONTO 20 + 30/60 | Experimental | 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. Receives: Drug: Toronto association; Other: Tadalafil placebo |
| TADALAFIL | Active comparator | 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. Receives: Drug: Tadalafil; Other: Toronto association placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (1)
Adverse events
Incidence and severity of adverse events recorded during the study.
Measured: 103 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study startJul 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052879
- Sponsor's protocol ID
- EMS0220 - TORONTO
- Status last verified
- Apr 2023
- First submitted
- 14 Sep 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05052879
- Acronym / sponsor ID
- EMS0220 - TORONTO
- Conditions
- Erectile Dysfunction, Premature Ejaculation
- Keywords
- Erectile dysfunction, Premature Ejaculation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Jul 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TORONTO 20 + 30/60 | Experimental | Drug: Toronto association, Other: Tadalafil placeboThe 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. |
| TADALAFIL | Active comparator | Drug: Tadalafil, Other: Toronto association placeboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toronto associationToronto association coated tablet, 20 mg + 30 mg or 20 mg + 60 mg, oral, 2 hours before the sexual intercourse. | Drug | TORONTO 20 + 30/60 |
| TadalafilTadalafil coated tablet, 20 mg, oral, 2 hours before the sexual intercourse. | Drug | TADALAFIL |
| Tadalafil placeboTadalafil placebo coated tablet, oral, 2 hours before the sexual intercourse. | Other | TORONTO 20 + 30/60 |
| Toronto association placeboToronto association placebo coated tablet, oral, 2 hours before the sexual intercourse. | Other | TADALAFIL |
Primary outcome
Percentage of participants with treatment response after 4 weeks of treatment.
Time frame: 4 weeks
The treatment response will be based on the participant's questionnaire answer after the treatment.
Percentage of participants with treatment response after 8 weeks of treatment.
Time frame: 8 weeks
The treatment response will be based on the participant's questionnaire answer after the treatment.
1 secondary outcome
Adverse events
Time frame: 103 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Toronto association and Tadalafil in people with Erectile Dysfunction and Premature Ejaculation, run by EMS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arthur M Kummer, MD (+551938879851, pesquisa.clinica@ncfarma.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with treatment response after 4 weeks of treatment. (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.