Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.

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

A Prospective Multicenter, Parallel Group Study With A Single Blind Phase And A Double Blind Randomised Phase, To Evaluate The Efficacy And Satisfaction Of Viagra (Sildenafil Citrate) High Dose (100mg) Titration Compared With 50mg Dose, In Men With Erectile Dysfunction

To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at the end of double blind treatment, comparing the group titrated to 100mg vs. the group maintained on 50mg.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

510

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

  • Canada
    • Ontario
      • Kitchener, Ontario, Canada
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada
        • Pfizer Investigational Site
    • Quebec
      • St. Leonard, Quebec, Canada
        • Pfizer Investigational Site
      • Trois-Rivieres, Quebec, Canada
        • Pfizer Investigational Site
  • France
      • LYON Cedex 03, France
        • Pfizer Investigational Site
      • Lille, France
        • Pfizer Investigational Site
      • Montpellier, France
        • Pfizer Investigational Site
      • PARIS cedex 18, France
        • Pfizer Investigational Site
  • Greece
      • Patras, Greece
        • Pfizer Investigational Site
      • Thessaloniki, Greece
        • Pfizer Investigational Site
    • Athens
      • Goudi, Athens, Greece
        • Pfizer Investigational Site
  • Israel
      • Beer Sheba, Israel
        • Pfizer Investigational Site
      • Haifa, Israel
        • Pfizer Investigational Site
      • Petach Tikva, Israel
        • Pfizer Investigational Site
      • Tel- Aviv, Israel
        • Pfizer Investigational Site
  • Italy
      • Bologna, Italy
        • Pfizer Investigational Site
      • Firenze, Italy
        • Pfizer Investigational Site
      • L'Aquila, Italy
        • Pfizer Investigational Site
      • Milano, Italy
        • Pfizer Investigational Site
      • Roma, Italy
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • Pfizer Investigational Site
  • Spain
      • Alicante, Spain
        • Pfizer Investigational Site
      • Barcelona, Spain
        • Pfizer Investigational Site
      • Madrid, Spain
        • Pfizer Investigational Site
      • Malaga, Spain
        • Pfizer Investigational Site
      • Sevilla, Spain
        • Pfizer Investigational Site
      • Valencia, Spain
        • Pfizer Investigational Site
    • Santa Cruz De Tenerife
      • La Laguna, Santa Cruz De Tenerife, Spain
        • Pfizer Investigational Site
  • United Kingdom
      • Bath, United Kingdom
        • Pfizer Investigational Site
      • Coventry, United Kingdom
        • Pfizer Investigational Site
      • Doncaster, United Kingdom
        • Pfizer Investigational Site
      • Dundee, United Kingdom
        • Pfizer Investigational Site
      • Glasgow, United Kingdom
        • Pfizer Investigational Site
    • Durham
      • Belmont, Durham, United Kingdom
        • Pfizer Investigational Site
    • Middlesex
      • Ashford, Middlesex, United Kingdom
        • Pfizer Investigational Site
    • Surrey
      • Weybridge, Surrey, United Kingdom
        • Pfizer Investigational Site
    • Wilts.
      • Chippenham, Wilts., United Kingdom
        • Pfizer Investigational Site
    • Wiltshire
      • Trowbridge, Wiltshire, United Kingdom
        • 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 ED by using IIEF-EF domain with score of ≤ 25.
  • Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse.

Exclusion Criteria:

  • Subjects in whom sexual activity is inadvisable in the opinion of the investigator such as significant cardiovascular disease in the last 6 months; including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation.
  • Subjects who are currently taking or are likely to be treated with nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or as aerosols) on either regular or intermittent basis.

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
Change in IIEF erectile function domain score at the end of double blind treatment.

Secondary Outcome Measures

Outcome Measure
Change in other IIEF domain scores; Response to other questionnaires regarding treatment satisfaction, safety and tolerability.

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

October 1, 2005

Study Registration Dates

First Submitted

November 3, 2005

First Submitted That Met QC Criteria

November 4, 2005

First Posted (Estimate)

November 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

  • A1481237

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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