Erectile Dysfunction
Conditions
Keywords
Healthy Volunteers
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effects on vision of six months of daily dosing of 5 mg tadalafil or 50 mg sildenafil compared with placebo.
Interventions
DRUGtadalafil
Sponsors
ICOS Corporation
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects or males with mild erectile dysfunction (ED). * Between the ages of 30 and 65 years, inclusive.
Exclusion criteria
* Phosphodiesterase type 5 (PDE5) inhibitor therapy (tadalafil, sildenafil, or vardenafil) within 6 weeks of the start of the study. * Diagnosis of diabetes mellitus. * Any chronic illness or medication that is a risk factor for eye disease or any medication that causes retinal toxicity or affects visual function. * Certain chronic medical conditions including unstable angina pectoris, severe renal \[kidney\] insufficiency, clinically significant hepatobiliary \[liver, bile duct\] disease, cancer, and AIDS/HIV. * A history of clinically significant chronic ophthalmologic disease or any significant visual abnormality identified at the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in dark-adapted bright flash b-wave amplitude on electroretinography (ERG) testing at baseline, 3 & 6 months on drug, and 4-6 weeks after discontinuation of drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Five other ERG waveform components; intraocular pressure; visual acuity; peripheral vision; color discrimination; and inspection of anterior chamber, lens, and retinal anatomy. | — |
Countries
United States
Outcome results
None listed