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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00143221
Enrollment
350
Registered
2005-09-02
Start date
2004-03-31
Completion date
2005-05-31
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impotence

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.

Interventions

DRUGViagra
DRUGPlacebo

Sponsors

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo—

Secondary

MeasureTime frame
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—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026