A Study of Visual Effects of Erectile Dysfunction Medications Dosed Daily for Six Months

Completed · Phase 4

Conditions studied: Erectile Dysfunction

In brief

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.

Key facts

Study ID

NCT00333281

Run by

Eli Lilly and Company

People needed

198

Starts

2005-06-01

Expected to finish

2006-08-01

Last updated by the study team

2007-10-25

Who can join

Age: 30 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy male subjects or males with mild erectile dysfunction (ED).
• Between the ages of 30 and 65 years, inclusive.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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