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

Phase 3

Not yet recruiting

• Conditions: Erectile Dysfunction; Premature Ejaculation
• Interventions: Drug: Toronto association; Drug: Tadalafil; Other: Tadalafil placebo; Other: Toronto association placebo

• Registration Number: NCT05052879
• Lead Sponsor: EMS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-14
• Study First Posted: 2021-09-22
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12
• Study Start: 2024-07
• Primary Completion: 2026-05
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 232

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TORONTO 20 + 30/60	Toronto association	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.
TORONTO 20 + 30/60	Tadalafil placebo	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.
TADALAFIL	Tadalafil	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.
TADALAFIL	Toronto association placebo	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.

Primary Outcome Measures

Name	Time	Method
Percentage of participants with treatment response after 4 weeks of treatment.	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.	8 weeks	The treatment response will be based on the participant's questionnaire answer after the treatment.

Secondary Outcome Measures

Name	Time	Method
Adverse events	103 days	Incidence and severity of adverse events recorded during the study.