Impotence
Conditions
Brief summary
Study to determine if men from around the world prefer sildenafil to tadalafil.
Interventions
DRUGtadalafil
20 mg tadalafil as needed by mouth no more than once a day for a 4 week initiation period and a 4 weeks treatment period.
DRUGsildenafil
Current dosage of sildenafil is continued for 4 weeks (no more than once a day) of treatment assessment then the wash-out period will begin.
Sponsors
ICOS Corporation
Eli Lilly and Company
Study design
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be of legal age according to your country. * Must have had a history of erectile dysfunction for at least 3 months. * Must currently and have been using sildenafil for the last six weeks. * Agree to not use any other ED treatment during the study. * Anticipate the same female sexual partner for the study.
Exclusion criteria
* History of other primary sexual disorder * Treatment with nitrates * Have a penile implant or clinically significant penile deformity * History of certain heart problems * Do not meet certain lab value reference ranges
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase | 14 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains. | 26 weeks |
Countries
Brazil
Outcome results
None listed