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

Primary Purpose

Impotence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Viagra (Sildenafil Citrate) 100 mg
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impotence

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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 Outcome Measures

Proportion (as above) of patients at various endpoints. Other questionnaires such as SEP, IIEF.

Full Information

First Posted
August 31, 2005
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00143260
Brief Title
Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impotence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Viagra (Sildenafil Citrate) 100 mg
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Proportion (as above) of patients at various endpoints. Other questionnaires such as SEP, IIEF.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Pfizer Investigational Site
City
Homewood
State/Province
Alabama
Country
United States
Facility Name
Pfizer Investigational Site
City
Hoover
State/Province
Alabama
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
La Mesa
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Newport Beach
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Pfizer Investigational Site
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
South Miami
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Tallahassee
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Wayne
State/Province
Indiana
Country
United States
Facility Name
Pfizer Investigational Site
City
Jeffersonville
State/Province
Indiana
Country
United States
Facility Name
Pfizer Investigational Site
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
Pfizer Investigational Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Pfizer Investigational Site
City
Bay Shore
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Kingston
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Spokane
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481240&StudyName=Study+Of+Men+With+Mild+To+Moderate+Erectile+Dysfunction+To+Evaluate+The+Efficacy+Of+Viagra+8+Hours+Post%2DDose
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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