QEQ Treatment Responsiveness Evaluation Study
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)
1 other identifier
interventional
100
1 country
9
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedFebruary 1, 2021
January 1, 2021
September 7, 2005
January 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment response to the Quality of Erection Questionnaire (QEQ) after treatment with Viagra in men with erectile dysfunction
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Pfizer Investigational Site
Bondi Junction, New South Wales, Australia
Pfizer Investigational Site
Darlinghurst, New South Wales, Australia
Pfizer Investigational Site
St Leonards, New South Wales, Australia
Pfizer Investigational Site
Spring Hill, Queensland, Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia
Pfizer Investigational Site
Clayton, Victoria, Australia
Pfizer Investigational Site
Malvern, Victoria, Australia
Pfizer Investigational Site
Mentone, Victoria, Australia
Pfizer Investigational Site
Nedlands, Western Australia, Australia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 9, 2005
Study Start
January 1, 2005
Last Updated
February 1, 2021
Record last verified: 2021-01