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

Phase 4

Completed

• Conditions: Erectile Dysfunction

• Registration Number: NCT00333281
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2006-05-31
• Study First Submitted QC: 2006-05-31
• Study First Posted: 2006-06-02
• Study Completion: 2006-08
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-23
• Last Update Posted: 2007-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 198

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (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