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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00333281
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : October 25, 2007
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: tadalafil Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : June 2005
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: tadalafil
    Other Names:
    • LY450190
    • Cialis
    • IC351

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Five other ERG waveform components; intraocular pressure; visual acuity; peripheral vision; color discrimination; and inspection of anterior chamber, lens, and retinal anatomy.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333281


Locations
United States, Indiana
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
Sponsors and Collaborators
Eli Lilly and Company
ICOS Corporation
Investigators
Study Director: 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) Eli Lilly and Company
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00333281     History of Changes
Other Study ID Numbers: 9520
H6D-MC-LVGO
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: October 25, 2007
Last Verified: October 2007

Keywords provided by Eli Lilly and Company:
Healthy Volunteers

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents