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

Sponsor

EMS (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05052879

Collaborator

(none)

232

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction Premature Ejaculation	Drug: Toronto association Drug: Tadalafil Other: Tadalafil placebo Other: Toronto association placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

232 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Adverse events [103 days]
Incidence and severity of adverse events recorded during the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.