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

Eli Lilly and Company1 site in 1 country198 target enrollmentJune 2005

ConditionsErectile Dysfunction

Drugstadalafil

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Erectile Dysfunction
Sponsor: Eli Lilly and Company
Enrollment: 198
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

August 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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 Outcomes

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