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

Primary Purpose

Impotence

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Sildenafil
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 - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

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

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

Secondary Outcome Measures

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

Full Information

First Posted
November 3, 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
NCT00249730
Brief Title
Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

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
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.

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
510 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sildenafil
Primary Outcome Measure Information:
Title
Change in IIEF erectile function domain score at the end of double blind treatment.
Secondary Outcome Measure Information:
Title
Change in other IIEF domain scores; Response to other questionnaires regarding treatment satisfaction, safety and tolerability.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Kitchener
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
St. Leonard
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Trois-Rivieres
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Lille
Country
France
Facility Name
Pfizer Investigational Site
City
LYON Cedex 03
Country
France
Facility Name
Pfizer Investigational Site
City
Montpellier
Country
France
Facility Name
Pfizer Investigational Site
City
PARIS cedex 18
Country
France
Facility Name
Pfizer Investigational Site
City
Goudi
State/Province
Athens
Country
Greece
Facility Name
Pfizer Investigational Site
City
Patras
Country
Greece
Facility Name
Pfizer Investigational Site
City
Thessaloniki
Country
Greece
Facility Name
Pfizer Investigational Site
City
Beer Sheba
Country
Israel
Facility Name
Pfizer Investigational Site
City
Haifa
Country
Israel
Facility Name
Pfizer Investigational Site
City
Petach Tikva
Country
Israel
Facility Name
Pfizer Investigational Site
City
Tel- Aviv
Country
Israel
Facility Name
Pfizer Investigational Site
City
Bologna
Country
Italy
Facility Name
Pfizer Investigational Site
City
Firenze
Country
Italy
Facility Name
Pfizer Investigational Site
City
L'Aquila
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
Country
Italy
Facility Name
Pfizer Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
La Laguna
State/Province
Santa Cruz De Tenerife
Country
Spain
Facility Name
Pfizer Investigational Site
City
Alicante
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
Country
Spain
Facility Name
Pfizer Investigational Site
City
Malaga
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
Country
Spain
Facility Name
Pfizer Investigational Site
City
Belmont
State/Province
Durham
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Ashford
State/Province
Middlesex
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Weybridge
State/Province
Surrey
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Chippenham
State/Province
Wilts.
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Trowbridge
State/Province
Wiltshire
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bath
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Coventry
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Doncaster
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dundee
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481237&StudyName=Titration+study+to+evaluate+efficacy+and+satisfaction+of+Viagra+in+men+with+erectile+function%2E
Description
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Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.

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