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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00143221

First received: August 31, 2005

Last updated: December 7, 2006

Last verified: December 2006

History of Changes

Purpose

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	Intervention	Phase
Impotence	Drug: Viagra Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction Urine and Urination

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	350
Study Start Date:	March 2004
Estimated Study Completion Date:	May 2005

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143221

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2008 Jul 2.

McVary 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. Epub 2007 Sep 20.

McVary 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.

ClinicalTrials.gov Identifier:	NCT00143221 History of Changes
Other Study ID Numbers:	A1481217
Study First Received:	August 31, 2005
Last Updated:	December 7, 2006
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Prostatic Hyperplasia
Hyperplasia
Erectile Dysfunction
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013

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