NCT05052879

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: EMS · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erectile Dysfunction
• Premature Ejaculation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-05-01
• Completion: 2026-08-01
• First posted: 2021-09-22
• Last updated: 2023-04-12