Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 31, 2005
Last updated: December 7, 2006
Last verified: December 2006

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
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:

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

Ages Eligible for Study:   45 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00143221

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

No publications provided by Pfizer

Additional publications automatically indexed to this study by Identifier (NCT Number): 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:
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Signs and Symptoms
Urological Manifestations processed this record on November 25, 2014