NCT05052879

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P25-P50 for phase_3

Timeline
2mo left

Started Jul 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Jul 2024Aug 2026

First Submitted

Initial submission to the registry

September 14, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
2.8 years until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

September 14, 2021

Last Update Submit

April 11, 2023

Conditions

Erectile DysfunctionPremature Ejaculation

Keywords

Erectile dysfunctionPremature Ejaculation

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    8 weeks

Secondary Outcomes (1)

  • Adverse events

    103 days

Study Arms (2)

TORONTO 20 + 30/60

EXPERIMENTAL

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 associationOther: Tadalafil placebo

TADALAFIL

ACTIVE COMPARATOR

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: TadalafilOther: Toronto association placebo

Interventions

Toronto associationDRUG

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

TORONTO 20 + 30/60
TadalafilDRUG

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

TADALAFIL
Tadalafil placeboOTHER

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

TORONTO 20 + 30/60
Toronto association placeboOTHER

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

TADALAFIL

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile DysfunctionPremature Ejaculation

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersEjaculatory Dysfunction

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Central Study Contacts

Arthur M Kummer, MD

CONTACT

+551938879851pesquisa.clinica@ncfarma.com.br

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2021

First Posted

September 22, 2021

Study Start

July 1, 2024

Primary Completion

May 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share