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NCT00143221 Clinical Trial

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

Impotence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00143221
Other study ID # A1481217
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 2004
Est. completion date May 2005

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date May 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 45 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Viagra

• Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo
Secondary Effect on: IPSS Effect on IPSS QoL Orgasmic Function
Secondary Sexual Desire Intercourse Satisfaction and Overall Satisfaction domains of IIEF Qmax by uroflometry
Secondary Event Log Variables
See also
  Status Clinical Trial Phase
Completed NCT00159848 - Effect Of A Treatment Optimization Program To Improve Satisfaction With Viagra Phase 4
Completed NCT00654082 - A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction Phase 4
Withdrawn NCT00382161 - Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors Phase 3
Completed NCT00882934 - The Management of Erectile Dysfunction With Placebo Only N/A
Recruiting NCT00297544 - Effect of Sildenafil on Endothelial Function N/A
Completed NCT00245596 - Evaluation of the Index of Sexual Life Questionnaire Phase 4
Completed NCT00249730 - Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function. Phase 4
Completed NCT00547183 - Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection Phase 3
Completed NCT00422578 - Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction Phase 4
Completed NCT00547092 - Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection Phase 4
Completed NCT00547508 - To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking Phase 3
Completed NCT00422734 - Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life Phase 3
Completed NCT00147628 - Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire Phase 4
Completed NCT00245258 - Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction Phase 4
Completed NCT00301262 - Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied Phase 4
Completed NCT00547287 - Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations Phase 3
Completed NCT03830164 - Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer Phase 2
Recruiting NCT00498680 - Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i Phase 4
Completed NCT00150358 - To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension . Phase 4
Completed NCT00547495 - Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection Phase 3