Impotence
Conditions
Brief summary
Study to see how effective different doses of tadalafil are for getting and keeping an erection when sex is attempted after a certain number of hours.
Interventions
DRUGtadalafil
10 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
DRUGplacebo
Placebo tablet taken by mouth, no more than once a day, anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
Sponsors
ICOS Corporation
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 3 months history of erectile dysfunction (ED) * Anticipate a monogamous relationship with a female sexual partner * Be able to make minimum required sexual intercourse attempts * Abstain from using any other ED treatment
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 |
|---|---|
| Prove superiority to placebo by measuring question 3 of the SEP diary | 6-10 and 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Compare effectiveness when patient can freely choose time of sex versus when time of sex attempt is set by the score of question 3 in the SEP diary | 6-10 and 24 weeks |
Countries
United States
Outcome results
None listed