QEQ Treatment Responsiveness Evaluation Study

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00151463
• Collaborator: (none)
• Enrollment: 100
• Locations: 9
• Patients Per Site: 11.1

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Jan 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Bondi Junction	New South Wales	Australia
2	Pfizer Investigational Site	Darlinghurst	New South Wales	Australia
3	Pfizer Investigational Site	St Leonards	New South Wales	Australia
4	Pfizer Investigational Site	Spring Hill	Queensland	Australia
5	Pfizer Investigational Site	Adelaide	South Australia	Australia
6	Pfizer Investigational Site	Clayton	Victoria	Australia
7	Pfizer Investigational Site	Malvern	Victoria	Australia
8	Pfizer Investigational Site	Mentone	Victoria	Australia
9	Pfizer Investigational Site	Nedlands	Western Australia	Australia

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00151463
• Other Study ID Numbers: A1481195
• First Posted: Sep 9, 2005
• Last Update Posted: Feb 1, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Erectile Dysfunction; Sildenafil Citrate

Study Results

No Results Posted as of Feb 1, 2021