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NCT00143260 Clinical Trial

Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose

Impotence Clinical Trial

Official title:
Multicenter Randomized Double-Blind, Placebo-Controlled, Fixed-Dose Parallel Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose - II

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00143260
Other study ID # A1481240
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 2005
Est. completion date May 2006

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Safety/Efficacy of 100mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date May 2006
Est. primary completion date May 2006
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Men 18-70 years of age - Documented clinical diagnosis of erectile dysfunction of at least 3 months duration. Exclusion Criteria: - Subjects with penile implants - Subjects with a known history of retinitis pigmentosa. - Subjects, due to the requirement of 100 mg dosage, who are receiving concomitant treatment with the potent CYP3A4 inhibitor ritonavir.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Viagra (Sildenafil Citrate) 100 mg

Locations
Country Name City State
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Bay Shore New York
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Des Moines Iowa
United States Pfizer Investigational Site Fort Wayne Indiana
United States Pfizer Investigational Site Gainesville Florida
United States Pfizer Investigational Site Homewood Alabama
United States Pfizer Investigational Site Hoover Alabama
United States Pfizer Investigational Site Huntsville Alabama
United States Pfizer Investigational Site Jeffersonville Indiana
United States Pfizer Investigational Site Kingston New York
United States Pfizer Investigational Site La Mesa California
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Newport Beach California
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Poughkeepsie New York
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Shreveport Louisiana
United States Pfizer Investigational Site South Miami Florida
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Tallahassee Florida
United States Pfizer Investigational Site Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 8 hrs after a dose of Viagra.
Secondary Proportion (as above) of patients at various endpoints. Other questionnaires such as SEP, IIEF.
See also
  Status Clinical Trial Phase
Completed NCT00159848 - Effect Of A Treatment Optimization Program To Improve Satisfaction With Viagra Phase 4
Completed NCT00654082 - A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction Phase 4
Withdrawn NCT00382161 - Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors Phase 3
Completed NCT00882934 - The Management of Erectile Dysfunction With Placebo Only N/A
Recruiting NCT00297544 - Effect of Sildenafil on Endothelial Function N/A
Completed NCT00245596 - Evaluation of the Index of Sexual Life Questionnaire Phase 4
Completed NCT00249730 - Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function. Phase 4
Completed NCT00422578 - Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction Phase 4
Completed NCT00547183 - Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection Phase 3
Completed NCT00547092 - Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection Phase 4
Completed NCT00547508 - To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking Phase 3
Completed NCT00422734 - Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life Phase 3
Completed NCT00301262 - Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied Phase 4
Completed NCT00147628 - Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire Phase 4
Completed NCT00245258 - Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction Phase 4
Completed NCT00547287 - Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations Phase 3
Completed NCT03830164 - Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer Phase 2
Recruiting NCT00498680 - Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i Phase 4
Completed NCT00150358 - To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension . Phase 4
Completed NCT00159809 - Efficacy Study Measuring The Impact Of Treatment With Viagra On The Depressive Symptoms Of Men With Erectile Dysfunction Phase 4

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