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QEQ Treatment Responsiveness Evaluation Study

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00151463
First received: September 7, 2005
Last updated: August 15, 2007
Last verified: August 2007
History of Changes
  Purpose

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 Intervention Phase
Impotence
 Drug: sildenafil citrate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

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

Estimated Enrollment: 100
Study Start Date: January 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00151463     History of Changes
Other Study ID Numbers: A1481195
Study First Received: September 7, 2005
Last Updated: August 15, 2007
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013