A Study of Visual Effects of Erectile Dysfunction Medications Dosed Daily for Six Months
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: tadalafil
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- Five other ERG waveform components; intraocular pressure; visual acuity; peripheral vision; color discrimination; and inspection of anterior chamber, lens, and retinal anatomy.
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Eli Lilly and Company Industry
Overall Clinical Trial Officials and Contacts
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 Eli Lilly and Company
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00333281
Study ID Number: 9520
ClinicalTrials.gov Identifier: NCT00333281
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00333281
