QEQ Treatment Responsiveness Evaluation Study

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.100 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Impotence

Interventions

sildenafil citrateDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

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

Pfizer Investigational Site

Outcomes

Primary Outcomes

Treatment response to the Quality of Erection Questionnaire (QEQ) after treatment with Viagra in men with erectile dysfunction

Secondary Outcomes

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

Data from ClinicalTrials.gov

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