Mild To Moderate Erectile Dysfunction Study

January 28, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

355

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, 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
    • Arizona
      • Phoenix, Arizona, United States
        • Pfizer Investigational Site
    • California
      • Beverly Hills, California, United States
        • Pfizer Investigational Site
      • La Mesa, California, United States
        • Pfizer Investigational Site
      • Newport Beach, California, United States
        • Pfizer Investigational Site
      • San Diego, California, United States
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States
        • Pfizer Investigational Site
    • Connecticut
      • Middlebury, Connecticut, United States
        • Pfizer Investigational Site
      • Waterbury, Connecticut, United States
        • Pfizer Investigational Site
    • Florida
      • Gainesville, Florida, United States
        • Pfizer Investigational Site
      • New Port Richey, Florida, United States
        • Pfizer Investigational Site
      • South Miami, Florida, United States
        • Pfizer Investigational Site
      • Tallahassee, Florida, United States
        • Pfizer Investigational Site
      • Tampa, Florida, United States
        • Pfizer Investigational Site
    • Indiana
      • Fort Wayne, Indiana, United States
        • Pfizer Investigational Site
      • Jeffersonville, Indiana, United States
        • Pfizer Investigational Site
    • Iowa
      • Des Moines, Iowa, United States
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • Pfizer Investigational Site
      • Shreveport, Louisiana, United States
        • Pfizer Investigational Site
    • Mississippi
      • Hattiesburg, Mississippi, United States
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Pfizer Investigational Site
    • New York
      • Bay Shore, New York, United States
        • Pfizer Investigational Site
      • Kingston, New York, United States
        • Pfizer Investigational Site
      • New York, New York, United States
        • Pfizer Investigational Site
      • Poughkeepsie, New York, United States
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States
        • Pfizer Investigational Site
    • Washington
      • Lacey, Washington, United States
        • Pfizer Investigational Site
      • Spokane, Washington, United States
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 12 hrs after a dose of Viagra. Other questionnaires such as SEP, IIEF.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion (ACTUAL)

February 1, 2006

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria

August 26, 2005

First Posted (ESTIMATE)

August 29, 2005

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1481230

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Impotence

Clinical Trials on Viagra (Sildenafil Citrate) 100 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe