Back to resultsEfficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation
Primary Purpose
Erectile Dysfunction, Premature Ejaculation
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Toronto association
Tadalafil
Tadalafil placebo
Toronto association placebo
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction, Premature Ejaculation
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TORONTO 20 + 30/60
TADALAFIL
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Adverse events
Incidence and severity of adverse events recorded during the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2024 (Anticipated)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Premature Ejaculation
Keywords
Erectile dysfunction, Premature Ejaculation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
232 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TORONTO 20 + 30/60
Arm Type
Experimental
Arm 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.
Arm Title
TADALAFIL
Arm Type
Active Comparator
Arm 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 Type
Drug
Intervention Name(s)
Toronto association
Intervention Description
Toronto association coated tablet, 20 mg + 30 mg or 20 mg + 60 mg, oral, 2 hours before the sexual intercourse.
Intervention Type
Drug
Intervention Name(s)
Tadalafil
Intervention Description
Tadalafil coated tablet, 20 mg, oral, 2 hours before the sexual intercourse.
Intervention Type
Other
Intervention Name(s)
Tadalafil placebo
Intervention Description
Tadalafil placebo coated tablet, oral, 2 hours before the sexual intercourse.
Intervention Type
Other
Intervention Name(s)
Toronto association placebo
Intervention Description
Toronto association placebo coated tablet, oral, 2 hours before the sexual intercourse.
Primary Outcome Measure Information:
Title
Percentage of participants with treatment response after 4 weeks of treatment.
Description
The treatment response will be based on the participant's questionnaire answer after the treatment.
Time Frame
4 weeks
Title
Percentage of participants with treatment response after 8 weeks of treatment.
Description
The treatment response will be based on the participant's questionnaire answer after the treatment.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Description
Incidence and severity of adverse events recorded during the study.
Time Frame
103 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arthur M Kummer, MD
Phone
+551938879851
Email
pesquisa.clinica@ncfarma.com.br
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation
We'll reach out to this number within 24 hrs