QEQ Treatment Responsiveness Evaluation Study

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).

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)

Conditions

Impotence

Study Type

Interventional

Study Design

Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Further Details

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

Study Start

January 2005

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Male

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

Total Enrolment

100

Contact Details

• Bondi Junction, New South Wales, Australia
• St Leonards, New South Wales, Australia
• Darlinghurst, New South Wales, Australia
• Spring Hill, Queensland, Australia
• ADELAIDE, South Australia, Australia
• Malvern, Victoria, Australia
• Mentone, Victoria, Australia
• Clayton, Victoria, Australia
• Nedlands, Western Australia, Australia

Contact Pfizer for more information