Back to resultsQEQ Treatment Responsiveness Evaluation Study
Primary Purpose
Impotence
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
sildenafil citrate
Sponsored by
About this trial
This is an interventional treatment trial for Impotence
Eligibility Criteria
Inclusion Criteria: Subjects must have documented clinical diagnosis of erectile dysfunction based on a screening SHI-M score of <21 and the subject fulfilling the NIH definition of erectile dysfunction Subjects must be either PDE-5 inhibitor naive; i.e. have never used sildenafil, tadalafil or vardenafil, or have been previously treated with no more than six doses of a PDE-5 inhibitor (sildenafil, tadalafil, vardenafil) and must have taken their last dose no less than 4 weeks prior to the screening visit Exclusion Criteria: Subjects who are 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
Sites / Locations
- 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
Treatment response to the Quality of Erection Questionnaire (QEQ) after treatment with Viagra in men with erectile dysfunction
Secondary Outcome Measures
Change from baseline to week 6 of the QEQ total score
Change from baseline to week 6 in the 5 IIEF domain scores
Change from baseline in scores of QEQ individual question
Full Information
NCT ID
NCT00151463
First Posted
September 7, 2005
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00151463
Brief Title
QEQ Treatment Responsiveness Evaluation Study
Official Title
An Open-Label, Non-Comparative Study To Evaluate Treatment Responsiveness To The Quality Of Erection Questionnaire (QEQ) In Men With Erectile Dysfunction Treated With Viagra (Sildenafil Citrate)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 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
The Quality of Erection Questionnaire (QEQ) is a new questionnaire that was developed to assess erectile attributes in men with erectile dysfunction. The study objective is to validate the Quality of Erection Questionnaire (QEQ) through the evaluation of subject responses to the QEQ regarding the quality and hardness of erections at baseline compared to subject responses post 6 and 10 weeks dosing with Viagra (sildenafil citrate).
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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sildenafil citrate
Primary Outcome Measure Information:
Title
Treatment response to the Quality of Erection Questionnaire (QEQ) after treatment with Viagra in men with erectile dysfunction
Secondary Outcome Measure Information:
Title
Change from baseline to week 6 of the QEQ total score
Title
Change from baseline to week 6 in the 5 IIEF domain scores
Title
Change from baseline in scores of QEQ individual question
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must have documented clinical diagnosis of erectile dysfunction based on a screening SHI-M score of <21 and the subject fulfilling the NIH definition of erectile dysfunction
Subjects must be either PDE-5 inhibitor naive; i.e. have never used sildenafil, tadalafil or vardenafil, or have been previously treated with no more than six doses of a PDE-5 inhibitor (sildenafil, tadalafil, vardenafil) and must have taken their last dose no less than 4 weeks prior to the screening visit
Exclusion Criteria:
Subjects who are 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
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
Bondi Junction
State/Province
New South Wales
Country
Australia
Facility Name
Pfizer Investigational Site
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
Pfizer Investigational Site
City
St Leonards
State/Province
New South Wales
Country
Australia
Facility Name
Pfizer Investigational Site
City
Spring Hill
State/Province
Queensland
Country
Australia
Facility Name
Pfizer Investigational Site
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Pfizer Investigational Site
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
Pfizer Investigational Site
City
Malvern
State/Province
Victoria
Country
Australia
Facility Name
Pfizer Investigational Site
City
Mentone
State/Province
Victoria
Country
Australia
Facility Name
Pfizer Investigational Site
City
Nedlands
State/Province
Western Australia
Country
Australia
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481195&StudyName=QEQ+Treatment+Responsiveness+Evaluation+Study
Description
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QEQ Treatment Responsiveness Evaluation Study
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