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

EMS

Status and phase: Not yet enrolling; Phase 3

Conditions: Erectile Dysfunction; Premature Ejaculation

Treatments: Other: Toronto association placebo; Drug: Tadalafil; Drug: Toronto association; Other: Tadalafil placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05052879

EMS0220 - TORONTO

Details and patient eligibility

About

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.

Enrollment: 232 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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232 participants in 2 patient groups

TORONTO 20 + 30/60

Experimental group

Description:

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.

Treatment:

Drug: Toronto association

Other: Tadalafil placebo

TADALAFIL

Active Comparator group

Description:

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.

Treatment:

Drug: Tadalafil

Other: Toronto association placebo