Impotence
Conditions
Brief summary
To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.
Interventions
DRUGtadalafil
10 mg or 20 mg tadalafil tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)
DRUGsildenafil
25 mg, 50 mg, or 100 mg sildenafil citrate tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)
Sponsors
ICOS Corporation
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of erection problems * Never taken treatments known as PDE5 inhibitors for erection issues * Abstain from using any other erection treatments during the study * Anticipate a monogamous female sexual relationship * Must be able to make required sexual intercourse attempts
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 |
|---|---|
| Preference Assessment measured by the Treatment Preference Question | 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Compare efficacies of the two drugs as measured by the Erectile Function domain of IIEF and Questions 2 and 3 of the SEP diary. | 0, 12, and 26 weeks |
| Assess sexual encounters attributes measured by the PAIRS. | 0, 12, and 26 weeks |
| Measure adverse events through the Side Effect Question. | 12 and 26 weeks |
Countries
United Kingdom
Outcome results
None listed