Impotence
Conditions
Brief summary
To compare men of different races and those with diabetes or depression to white men that do not have diabetes or depression but also suffer from the inability to get or keep an erection.
Interventions
DRUGtadalafil
20 mg tadalafil tablet taken by mouth, as needed, no more than once a day, for 12 weeks.
Sponsors
ICOS Corporation
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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
* Other primary sexual disorders * History of penile implant or clinically significant penile deformity * History or current nitrate use * History of certain heart problems * History of certain kidney problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the scores of the IIEF scale's Erectile Function domain, questions 1-5 and 15 | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Yes answers to questions 2 and 3 of the Sexual Encounter Profile | 12 weeks |
| Evaluation of score changes for selected GAQ, PAIRS, and IIEF questions. | 12 weeks |
Countries
United States
Outcome results
None listed