QEQ Treatment Responsiveness Evaluation Study

Impotence Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151463
• Other study ID #: A1481195
• Status: Completed
• Phase: Phase 4
• Start date: January 2005

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Impotence

Intervention

Drug:
• sildenafil citrate

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Adelaide	South Australia
Australia	Pfizer Investigational Site	Bondi Junction	New South Wales
Australia	Pfizer Investigational Site	Clayton	Victoria
Australia	Pfizer Investigational Site	Darlinghurst	New South Wales
Australia	Pfizer Investigational Site	Malvern	Victoria
Australia	Pfizer Investigational Site	Mentone	Victoria
Australia	Pfizer Investigational Site	Nedlands	Western Australia
Australia	Pfizer Investigational Site	Spring Hill	Queensland
Australia	Pfizer Investigational Site	St Leonards	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment response to the Quality of Erection Questionnaire (QEQ) after treatment with Viagra in men with erectile dysfunction
Secondary	Change from baseline to week 6 of the QEQ total score
Secondary	Change from baseline to week 6 in the 5 IIEF domain scores
Secondary	Change from baseline in scores of QEQ individual question

External Links

•   To obtain contact information for a study center near you, click here.