Official Title: “A Randomized, Double-Blind, Parallel-Design, Placebo-Controlled Study to Evaluate the Effects of 5 mg Tadalafil (IC351, LY450190) and 50 mg Sildenafil Administered Once Daily for 6 Months on Visual Function in Healthy Subjects or Subjects With Mild Erectile Dysfunction”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Intervention(s) in this Clinical Trial

• Drug: tadalafil

Primary Measures

• 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 Measures

• Five other ERG waveform components; intraocular pressure; visual acuity; peripheral vision; color discrimination; and inspection of anterior chamber, lens, and retinal anatomy.

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00333281

Study ID Number: 9520

ClinicalTrials.gov Identifier: NCT00333281

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry