A Study Of The Safety and Efficacy Of Viagra In Men With Erectile Dysfunction Who Do Not Self Identify.
- Registration Number
- NCT00343200
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 371
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sildenafil Viagra (sildenafil citrate) - Placebo Placebo -
- Primary Outcome Measures
Name Time Method To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF). Week 8
- Secondary Outcome Measures
Name Time Method Safety and Tolerability up to 12 Weeks 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Oregon, Wisconsin, United States
Pfizer Investigational Site🇺🇸Oregon, Wisconsin, United States