Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH)
A Multicenter, Randomized, Parallel Group, Double-blind, Placebo-controlled Flexible Dose Study With and Open-label Extension to Assess the Efficacy and Safety of Viagra (Sildenafil Citrate) in the Treatment of Men With Erectile Dysfunction (ED) and Concomitant Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) in the United States
1 other identifier
interventional
350
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2004
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 31, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedFebruary 1, 2021
January 1, 2021
August 31, 2005
January 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- clinical diagnosis of erectile dysfunction (ED)
- lower urinary tract symptoms (LUTS)
You may not qualify if:
- previous prostate surgery or invasive intervention for BPH
- active urinary tract disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
McVary KT, Siegel RL, Carlsson M. Sildenafil citrate improves erectile function and lower urinary tract symptoms independent of baseline body mass index or LUTS severity. Urology. 2008 Sep;72(3):575-9. doi: 10.1016/j.urology.2008.04.020. Epub 2008 Jul 2.
PMID: 18597830DERIVEDMcVary KT, Kaufman J, Young JM, Tseng LJ. Sildenafil citrate improves erectile function: a randomised double-blind trial with open-label extension. Int J Clin Pract. 2007 Nov;61(11):1843-9. doi: 10.1111/j.1742-1241.2007.01585.x. Epub 2007 Sep 20.
PMID: 17887993DERIVEDMcVary KT, Monnig W, Camps JL Jr, Young JM, Tseng LJ, van den Ende G. Sildenafil citrate improves erectile function and urinary symptoms in men with erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, double-blind trial. J Urol. 2007 Mar;177(3):1071-7. doi: 10.1016/j.juro.2006.10.055.
PMID: 17296414DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 2, 2005
Study Start
March 1, 2004
Study Completion
May 1, 2005
Last Updated
February 1, 2021
Record last verified: 2021-01