A Study Of The Safety and Efficacy Of Viagra In Men With Erectile Dysfunction Who Do Not Self Identify.

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

A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Flexible-Dose Study To Assess The Efficacy And Safety Of Viagra (Sildenafil Citrate) In Men With Erectile Dysfunction (ED) Who Do Not Self Identify.

To compare the efficacy and safety of Viagra (sildenafil citrate) vs. placebo for the treatment of men with ED and at least 1 prespecified risk factor who do not self identify as having ED.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

371

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
      • Huntsville, Alabama, United States, 35801
        • Pfizer Investigational Site
    • Arizona
      • Mesa, Arizona, United States, 85213
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85051
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85023
        • Pfizer Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Pfizer Investigational Site
      • Beverly Hills, California, United States, 90211
        • Pfizer Investigational Site
      • Huntington Beach, California, United States, 92648
        • Pfizer Investigational Site
      • San Diego, California, United States, 92123
        • Pfizer Investigational Site
      • Santa Rosa, California, United States, 95405
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Pfizer Investigational Site
      • Colorado Springs, Colorado, United States, 80904
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80212
        • Pfizer Investigational Site
    • Connecticut
      • Avon, Connecticut, United States, 06001
        • Pfizer Investigational Site
      • Manchester, Connecticut, United States, 06040
        • Pfizer Investigational Site
    • Delaware
      • Wilmington, Delaware, United States, 19801
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Pfizer Investigational Site
    • Florida
      • Hollywood, Florida, United States, 33021
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34474
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, United States, 33024
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33607
        • Pfizer Investigational Site
    • Illinois
      • Peoria, Illinois, United States, 61602
        • Pfizer Investigational Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Pfizer Investigational Site
    • Kansas
      • Arkansas City, Kansas, United States, 67005
        • Pfizer Investigational Site
      • Newton, Kansas, United States, 67114
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States, 66215
        • Pfizer Investigational Site
      • Wichita, Kansas, United States, 67207
        • Pfizer Investigational Site
      • Wichita, Kansas, United States, 67205
        • Pfizer Investigational Site
    • Michigan
      • Livonia, Michigan, United States, 48152
        • Pfizer Investigational Site
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • Pfizer Investigational Site
    • New York
      • Binghamton, New York, United States, 13901
        • Pfizer Investigational Site
      • Endwell, New York, United States, 13760
        • Pfizer Investigational Site
      • New York, New York, United States, 10016
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Pfizer Investigational Site
      • Mogadore, Ohio, United States, 44260
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74136
        • Pfizer Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Pfizer Investigational Site
      • Simpsonville, South Carolina, United States, 29681
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84121
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site
    • Washington
      • Spokane, Washington, United States, 99207
        • Pfizer Investigational Site
      • Tacoma, Washington, United States, 98405
        • Pfizer Investigational Site
    • Wisconsin
      • Oregon, Wisconsin, United States, 53575
        • 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

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men who do not identify as having ED with documented ED
  • Men 30 years of age and older
  • At least one prespecified risk factor for ED

Exclusion Criteria:

  • Subjects currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis
  • Subjects with a known history of retinitis pigmentosa.

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo tablet orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 8 weeks (DB phase). In 4-week OL phase, subjects received sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period.
Experimental: Sildenafil
Drug: Viagra (sildenafil citrate)
Sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 12 weeks (8-week DB phase and 4-week OL phase).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF).
Time Frame: Week 8
Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Other questionnaires and variables such as IIEF, SEAR, GEAQ, SEX-Q, QEQ, EDITS, SEP, Event Log, Erection Hardness Grading Score, and Morisky Compliance.
Time Frame: Weeks 8 and 12
Weeks 8 and 12
Safety and Tolerability
Time Frame: up to 12 Weeks
up to 12 Weeks

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.

General Publications

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

July 1, 2006

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

June 20, 2006

First Submitted That Met QC Criteria

June 20, 2006

First Posted (Estimate)

June 22, 2006

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

  • A1481247

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.

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