Impotence
Conditions
Brief summary
To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at the end of double blind treatment, comparing the group titrated to 100mg vs. the group maintained on 50mg.
Interventions
DRUGSildenafil
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Documented clinical diagnosis of ED by using IIEF-EF domain with score of ≤ 25. * Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse.
Exclusion criteria
* Subjects in whom sexual activity is inadvisable in the opinion of the investigator such as significant cardiovascular disease in the last 6 months; including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation. * Subjects who are currently taking or are likely to be treated with nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or as aerosols) on either regular or intermittent basis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in IIEF erectile function domain score at the end of double blind treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in other IIEF domain scores; Response to other questionnaires regarding treatment satisfaction, safety and tolerability. | — |
Countries
Canada, France, Greece, Israel, Italy, Russia, Spain, United Kingdom
Outcome results
None listed