Health TrialsbyHealthPanel

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

ConditionsErectile DysfunctionPremature Ejaculation
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorEMS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Toronto association

    Drug

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

  • Tadalafil

    Drug

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

  • Tadalafil placebo

    Other intervention

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

  • Toronto association placebo

    Other intervention

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

Treatment groups

232 Participants
are divided into 2 treatment groups
Group A: TORONTO 20 + 30/60Experimental treatment 2 interventions
Group B: TADALAFILActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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

1

Adverse events

Incidence and severity of adverse events recorded during the study.

Time frame
103 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EMS

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: