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

Lilly

Status and phase

Completed

Phase 4

Conditions

Erectile Dysfunction

Treatments

Drug: tadalafil

Study type

Interventional

Funder types

Industry

Identifiers

NCT00333281

H6D-MC-LVGO

9520

Details and patient eligibility

About

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.

Sex

Male

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.