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

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00143221
• Collaborator: (none)
• Enrollment: 350
• Duration (Months): 14

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Mar 1, 2004
• Study Completion Date: May 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00143221
• Other Study ID Numbers: A1481217
• First Posted: Sep 2, 2005
• Last Update Posted: Feb 1, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Prostatic Hyperplasia; Erectile Dysfunction; Hyperplasia; Sildenafil Citrate

Study Results

No Results Posted as of Feb 1, 2021