Erectile Dysfunction
Conditions
Keywords
Impotence, erectile dysfunction, semen, sperm, Healthy male volunteers, men with mild erectile dysfunction
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel design study to evaluate effects on semen characteristics after 40 weeks of daily dosing with 20 mg tadalafil.
Interventions
DRUGtadalafil
20mg tadalafil tablet taken by mouth once a day for 40 weeks
DRUGplacebo
Placebo tablet taken by mouth once a day for 40 weeks
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
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects or men with mild erectile dysfunction * At least 45 years of age * With specified semen characteristics.
Exclusion criteria
* Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV * A history of certain endocrine or hormonal abnormalities * A history of significant testicular/genital abnormalities * Any significant reproductive abnormality identified at the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in sperm production measured at baseline and after 9 months of treatment. | 40 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in other semen characteristics and reproductive hormones. | 40 weeks |
Countries
United States
Outcome results
None listed