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

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Erectile Dysfunction

Intervention: tadalafil (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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, Affiliation: Eli Lilly and Company

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

Eligibility

Minimum age: 30 Years. Maximum age: 65 Years. Gender(s): Male.

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.

Locations and Contacts

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
Additional Information

Lilly Clinical Trial Registry

Starting date: June 2005
Last updated: October 23, 2007

Page last updated: August 20, 2015

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