Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00151463




Registration number
NCT00151463
Ethics application status
Date submitted
7/09/2005
Date registered
9/09/2005
Date last updated
1/02/2021

Titles & IDs
Public title
QEQ Treatment Responsiveness Evaluation Study
Scientific 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)
Secondary ID [1] 0 0
A1481195
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impotence 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Mental Health 0 0 0 0
Other mental health disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - sildenafil citrate

Treatment: Drugs: sildenafil citrate
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment response to the Quality of Erection Questionnaire (QEQ) after treatment with Viagra in men with erectile dysfunction
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Change from baseline to week 6 of the QEQ total score
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Change from baseline to week 6 in the 5 IIEF domain scores
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Change from baseline in scores of QEQ individual question
Timepoint [3] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Bondi Junction
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
Pfizer Investigational Site - St Leonards
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Spring Hill
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Clayton
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Malvern
Recruitment hospital [8] 0 0
Pfizer Investigational Site - Mentone
Recruitment hospital [9] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Bondi Junction
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- St Leonards
Recruitment postcode(s) [4] 0 0
- Spring Hill
Recruitment postcode(s) [5] 0 0
- Adelaide
Recruitment postcode(s) [6] 0 0
- Clayton
Recruitment postcode(s) [7] 0 0
- Malvern
Recruitment postcode(s) [8] 0 0
- Mentone
Recruitment postcode(s) [9] 0 0
- Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00151463
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00151463