Impotence
Conditions
Brief summary
Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.
Interventions
DRUGtadalafil
5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
DRUGplacebo
placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks
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
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
* Other primary sexual disorders * History of radical prostatectomy or other pelvic surgery that affected being able to have an erection * History of penile implant or clinically significant penile deformity. * Nitrate use * Certain heart problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in SEP diary | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to endpoint of various questions from the IIEF and SEP diary | 12 weeks |
Countries
Japan
Outcome results
None listed