Impotence
Conditions
Brief summary
To compare the efficacy and safety of Viagra (sildenafil citrate) vs. placebo for the treatment of men with ED and at least 1 prespecified risk factor who do not self identify as having ED.
Interventions
Sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 12 weeks (8-week DB phase and 4-week OL phase).
DRUGPlacebo
Placebo tablet orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 8 weeks (DB phase). In 4-week OL phase, subjects received sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men who do not identify as having ED with documented ED * Men 30 years of age and older * At least one prespecified risk factor for ED
Exclusion criteria
* Subjects 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 * Subjects with a known history of retinitis pigmentosa.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF). | Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Other questionnaires and variables such as IIEF, SEAR, GEAQ, SEX-Q, QEQ, EDITS, SEP, Event Log, Erection Hardness Grading Score, and Morisky Compliance. | Weeks 8 and 12 |
| Safety and Tolerability | up to 12 Weeks |
Countries
United States
Outcome results
None listed