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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Erectile Dysfunction; Premature Ejaculation
• Intervention / Treatment: Drug: Toronto association; Other: Tadalafil placebo; Drug: Tadalafil; Other: Toronto association placebo

• Study Type: Interventional
• Enrollment (Anticipated): 232
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Arthur M Kummer, MD; Phone Number: +551938879851; Email: pesquisa.clinica@ncfarma.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TORONTO 20 + 30/60; 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; Toronto association coated tablet, 20 mg + 30 mg or 20 mg + 60 mg, oral, 2 hours before the sexual intercourse.; Other: Tadalafil placebo; Tadalafil placebo coated tablet, oral, 2 hours before the sexual intercourse.
Active Comparator: 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.	Drug: Tadalafil; Tadalafil coated tablet, 20 mg, oral, 2 hours before the sexual intercourse.; Other: Toronto association placebo; Toronto association placebo coated tablet, oral, 2 hours before the sexual intercourse.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2024
• Primary Completion (Anticipated): May 1, 2026
• Study Completion (Anticipated): August 1, 2026

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Erectile dysfunction; Premature Ejaculation
• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Sexual Dysfunctions, Psychological; Obstetric Labor, Premature; Sexual Dysfunction, Physiological; Premature Birth; Erectile Dysfunction; Premature Ejaculation; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: EMS0220 - TORONTO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No