Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00143221
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : December 11, 2006
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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.

Condition or disease Intervention/treatment Phase
Impotence Drug: Viagra Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2004
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo

Secondary Outcome Measures :
  1. Effect on: IPSS Effect on IPSS QoL Orgasmic Function
  2. Sexual Desire Intercourse Satisfaction and Overall Satisfaction domains of IIEF Qmax by uroflometry
  3. Event Log Variables

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00143221

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00143221     History of Changes
Other Study ID Numbers: A1481217
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: December 11, 2006
Last Verified: December 2006

Additional relevant MeSH terms:
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Erectile Dysfunction
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents