Status:
COMPLETED
A Study of Visual Effects of Erectile Dysfunction Medications Dosed Daily for Six Months
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
ICOS Corporation
Conditions:
Erectile Dysfunction
Eligibility:
MALE
30-65 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- Healthy male subjects or males with mild erectile dysfunction (ED).
- Between the ages of 30 and 65 years, inclusive.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00333281
Start Date
June 1 2005
End Date
August 1 2006
Last Update
October 25 2007
Active Locations (1)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Indianapolis, Indiana, United States