Impotence
Conditions
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).
Interventions
DRUGsildenafil citrate
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment response to the Quality of Erection Questionnaire (QEQ) after treatment with Viagra in men with erectile dysfunction | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Australia
Outcome results
None listed