Not yet recruitingNCT05052879Updated Apr 12, 2023

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

A Phase 3 interventional study of Toronto association and Tadalafil in Erectile Dysfunction and Premature Ejaculation, sponsored by EMS. Not yet recruiting. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-12.

Sponsored by EMS · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 232
Allocation: Randomized
Ages: 18 Years and older
Sex: Male

Study 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 studied

Erectile Dysfunction
Premature Ejaculation

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Keywords

Erectile dysfunction
Premature Ejaculation

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 232 participants (estimated)

Study arms

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 · Other: Tadalafil placebo
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 · Other: Toronto association placebo

Interventions

DrugToronto association
Toronto association coated tablet, 20 mg + 30 mg or 20 mg + 60 mg, oral, 2 hours before the sexual intercourse.
DrugTadalafil
Tadalafil coated tablet, 20 mg, oral, 2 hours before the sexual intercourse.
OtherTadalafil placebo
Tadalafil placebo coated tablet, oral, 2 hours before the sexual intercourse.
OtherToronto association placebo
Toronto association placebo coated tablet, oral, 2 hours before the sexual intercourse.

What researchers measure

Primary outcomes

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.
Time frame: 4 weeks
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.
Time frame: 8 weeks

Secondary outcomes

Adverse events
Incidence and severity of adverse events recorded during the study.
Time frame: 103 days

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT05052879
Lead sponsor: EMS
Responsible party: Sponsor
First posted: Sep 22, 2021
Start date: Jul 2024 (estimated)
Primary completion: May 2026 (estimated)
Completion: Aug 2026 (estimated)
Last update: Apr 12, 2023

Study contacts

Arthur M Kummer, MD

Contact

pesquisa.clinica@ncfarma.com.br

+551938879851

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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