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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05052879
• Other study ID #: EMS0220 - TORONTO
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 2024
• Est. completion date: August 2026

Study information

• Verified date: April 2023
• Source: EMS
• Contact: Arthur M Kummer, MD
• Phone: +551938879851
• Email: pesquisa.clinica[@]ncfarma.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 232
• Est. completion date: August 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Premature Birth
• Premature Ejaculation

Intervention

Drug:
• Toronto association
Toronto association coated tablet, 20 mg + 30 mg or 20 mg + 60 mg, oral, 2 hours before the sexual intercourse.
• 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.
• Toronto association placebo
Toronto association placebo coated tablet, oral, 2 hours before the sexual intercourse.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Adverse events	Incidence and severity of adverse events recorded during the study.	103 days