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
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