## Protocol Section
### Identification Module
**NCT ID:** NCT05052879

**Brief Title:** Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation

**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

#### Organization Study ID Info
**ID:** EMS0220 - TORONTO
#### Organization
**Class:** INDUSTRY
**Full Name:** EMS
### Status Module
#### Completion Date
**Date:** 2026-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-04-12

**Type:** ACTUAL

**Last Update Submit Date:** 2023-04-11

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2023-04

#### Study First Post Date
**Date:** 2021-09-22
**Type:** ACTUAL
**Study First Submit Date:** 2021-09-14
**Study First Submit QC Date:** 2021-09-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** EMS

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Erectile Dysfunction

- Premature Ejaculation

**Keywords:**

- Erectile dysfunction

- Premature Ejaculation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 232

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Drug: Toronto association

- Other: Tadalafil placebo

**Label:** TORONTO 20 + 30/60

**Type:** EXPERIMENTAL

#### Arm Group 2

**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.

**Intervention Names:**

- Drug: Tadalafil

- Other: Toronto association placebo

**Label:** TADALAFIL

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TORONTO 20 + 30/60

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

**Name:** Toronto association

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- TADALAFIL

**Description:** Tadalafil coated tablet, 20 mg, oral, 2 hours before the sexual intercourse.

**Name:** Tadalafil

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- TORONTO 20 + 30/60

**Description:** Tadalafil placebo coated tablet, oral, 2 hours before the sexual intercourse.

**Name:** Tadalafil placebo

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- TADALAFIL

**Description:** Toronto association placebo coated tablet, oral, 2 hours before the sexual intercourse.

**Name:** Toronto association placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The treatment response will be based on the participant's questionnaire answer after the treatment.

**Measure:** Percentage of participants with treatment response after 4 weeks of treatment.

**Time Frame:** 4 weeks

**Description:** The treatment response will be based on the participant's questionnaire answer after the treatment.

**Measure:** Percentage of participants with treatment response after 8 weeks of treatment.

**Time Frame:** 8 weeks

#### Secondary Outcomes

**Description:** Incidence and severity of adverse events recorded during the study.

**Measure:** Adverse events

**Time Frame:** 103 days

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** pesquisa.clinica@ncfarma.com.br

**Name:** Arthur M Kummer, MD

**Phone:** +551938879851

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007752

- Term: Obstetric Labor, Premature

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000012735

- Term: Sexual Dysfunction, Physiological

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000020018

- Term: Sexual Dysfunctions, Psychological

- ID: D000001523

- Term: Mental Disorders

- ID: D000097910

- Term: Ejaculatory Dysfunction

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M25869

- Name: Premature Birth

- Relevance: HIGH

- As Found: Premature

- ID: M29853

- Name: Premature Ejaculation

- Relevance: HIGH

- As Found: Premature Ejaculation

- ID: M10217

- Name: Erectile Dysfunction

- Relevance: HIGH

- As Found: Erectile Dysfunction

- ID: M10772

- Name: Obstetric Labor, Premature

- Relevance: LOW

- As Found: Unknown

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M15546

- Name: Sexual Dysfunction, Physiological

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21873

- Name: Sexual Dysfunctions, Psychological

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M3452

- Name: Ejaculatory Dysfunction

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000047928

- Term: Premature Birth

- ID: D000007172

- Term: Erectile Dysfunction

- ID: D000061686

- Term: Premature Ejaculation

### Intervention Browse Module - Ancestors

- ID: D000014665

- Term: Vasodilator Agents

- ID: D000058986

- Term: Phosphodiesterase 5 Inhibitors

- ID: D000010726

- Term: Phosphodiesterase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000064804

- Term: Urological Agents

### Intervention Browse Module - Browse Branches

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: Urol

- Name: Urological Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M279

- Name: Tadalafil

- Relevance: HIGH

- As Found: Gestational

- ID: M17412

- Name: Vasodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M29332

- Name: Phosphodiesterase 5 Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M13629

- Name: Phosphodiesterase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068581

- Term: Tadalafil

### Misc Info Module

- Version Holder: 2024-05-24
