Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH)
Phase 4
Completed
- Conditions
- Impotence
- Registration Number
- NCT00143221
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The purpose of this study is to determine whether Viagra is effective in treating erectile dysfunction and lower urinary tract symptoms in men affected by both conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 350
Inclusion Criteria
- clinical diagnosis of erectile dysfunction (ED)
- lower urinary tract symptoms (LUTS)
Exclusion Criteria
- previous prostate surgery or invasive intervention for BPH
- active urinary tract disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo
- Secondary Outcome Measures
Name Time Method Effect on: IPSS Effect on IPSS QoL Orgasmic Function Sexual Desire Intercourse Satisfaction and Overall Satisfaction domains of IIEF Qmax by uroflometry Event Log Variables