Impotence
Conditions
Brief summary
The study objective is to: 1. To evaluate the effect of sildenafil citrate versus placebo on the IIEF\_EF Domain at the end of the double-blind phase 2. To assess the relationship between treatment with sildenafil citrate or placebo and responses to the Quality of Erection Questionnaire (QEQ) and Sexual Experience Questionnaire (SEX\_Q).
Interventions
DRUGSildenafil Citrate
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male subjects aged 18-65. * Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.)
Exclusion criteria
* Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction \[Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening\].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change from baseline to Visit 4 (Week 8) in the IIEF Erectile Function (EF) domain score. | — |
Secondary
| Measure | Time frame |
|---|---|
| The change from baseline to visit 6 (wk 12) in the IIEF-EF domain; the change from baseline to visit 4 (wk 8) and visit 6 (wk 12) in the domains and total score as well as the individual questions of the sexual experience questionnaire | — |
Countries
Russia, South Korea, Spain, Sweden
Outcome results
None listed