Erectile Dysfunction, Premature Ejaculation
Conditions
Keywords
Erectile dysfunction, Premature Ejaculation
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.
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.
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with treatment response after 4 weeks of treatment. | 4 weeks | 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. | 8 weeks | The treatment response will be based on the participant's questionnaire answer after the treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 103 days | Incidence and severity of adverse events recorded during the study. |
Contacts
Primary ContactArthur M Kummer, MD
Outcome results
None listed