Impotence
Conditions
Brief summary
Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection.
Interventions
DRUGtadalafil
10 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
DRUGplacebo
placebo tablet taken by mouth as needed for 12 weeks not more than once a day
Sponsors
ICOS Corporation
Eli Lilly and Company
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
* History of erection problems * Anticipate a monogamous female sexual relationship * Abstain from other erection treatments at least 4 weeks before first dose and throughout the study * Must be able to make required sexual intercourse attempts
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 |
|---|---|
| IIEF Erectile Function Domain score from Questions 1-5 and 15. SEP Diary responses to Questions 2-3 and the entire Diary for baseline and endpoint scores. | 4, 8, and 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| IIEF questions and scores, Global Assessment Questions, Patient's SEP Diary | 12 weeks |
Countries
China
Outcome results
None listed