Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire

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

A Multi-Center, Double-Blind Placebo Controlled, Flexible-Dose Study With An Open-Label Phase To Assess The Efficacy Of Sildenafil Citrate On Erectile Function And Intercourse Satisfaction As Well As To Validate The Sexual Experience Questionnaire And Its Treatment Responsiveness In Men With Erectile Dysfunction

To evaluate the effectiveness of sildenafil on erectile function and intercourse satisfaction in men with ED as well as to validate the new Sexual Experience Questionnaire which incorporates functional and emotional elements of a man's sexual experience into one comprehensive questionnaire.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

209

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
        • Pfizer Investigational Site
    • California
      • San Diego, California, United States
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, United States
        • Pfizer Investigational Site
      • Ocala, Florida, United States
        • Pfizer Investigational Site
      • Tallahassee, Florida, United States
        • Pfizer Investigational Site
    • Indiana
      • Jeffersonville, Indiana, United States
        • Pfizer Investigational Site
    • Iowa
      • Des Moines, Iowa, United States
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Pfizer Investigational Site
    • New York
      • Garden City, 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
    • North Dakota
      • Fargo, North Dakota, United States
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States
        • Pfizer Investigational Site
      • San Antonio, Texas, United States
        • Pfizer Investigational Site
    • Washington
      • Seattle, 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Documented clinical diagnosis of erectile dysfunction, defined by a score of less than or equal to 25 on the Erectile Dysfunction domain of the International Index of Erectile Function

Exclusion Criteria:

  • Subjects who have been treated with more than 6 doses of sildenafil or any other phosphodiesterase type 5 inhibitor

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary endpoints are: The changes from baseline to Visit 5 (Week 10) of the Erectile Function (Questions 1-5, 15) Intercourse Satisfaction domains (Questions 6-8) of the International Index of Erectile Function (IIEF).

Secondary Outcome Measures

Outcome Measure
The change from baseline to Visit 4 (Week 6), Visit 5 (Week 10) and Visit 7 (Week 16) in the domains and total score as well as the individual questions of the Sexual Experience Questionnaire (SEX-Q)

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

November 1, 2005

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

September 4, 2005

First Submitted That Met QC Criteria

September 4, 2005

First Posted (Estimate)

September 7, 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

  • A1481236

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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