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QEQ Treatment Responsiveness Evaluation Study

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ClinicalTrials.gov Identifier: NCT00151463
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : August 16, 2007
Sponsor:
Information provided by:
Pfizer

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).

Condition or disease Intervention/treatment Phase
Impotence Drug: sildenafil citrate Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Treatment response to the Quality of Erection Questionnaire (QEQ) after treatment with Viagra in men with erectile dysfunction

Secondary Outcome Measures :
  1. Change from baseline to week 6 of the QEQ total score
  2. Change from baseline to week 6 in the 5 IIEF domain scores
  3. Change from baseline in scores of QEQ individual question


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151463


Locations
Australia, New South Wales
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
Australia, Queensland
Pfizer Investigational Site
Spring Hill, Queensland, Australia
Australia, South Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia
Australia, Victoria
Pfizer Investigational Site
Clayton, Victoria, Australia
Pfizer Investigational Site
Malvern, Victoria, Australia
Pfizer Investigational Site
Mentone, Victoria, Australia
Australia, Western Australia
Pfizer Investigational Site
Nedlands, Western Australia, Australia
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
ClinicalTrials.gov Identifier: NCT00151463     History of Changes
Other Study ID Numbers: A1481195
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: August 16, 2007
Last Verified: August 2007

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Citric Acid
Sildenafil Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents