Not Signed In -
Impotence |
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Clinical Trial: Effectiveness and Safety of Viagra in Men with ED and LUTS Due to Benign Prostatic Hyperplasia (BPH)
This study is no longer recruiting patients.
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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 IV |
MedlinePlus related topics: Erectile Dysfunction
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo-Controlled Flexible Dose Study with an 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
Further Study Details:
Primary Outcomes: Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo
Secondary Outcomes: 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 QoL by BPH Impact Questionnaire EDITS
Expected Total Enrollment: 350
Secondary Outcomes: 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 QoL by BPH Impact Questionnaire EDITS
Expected Total Enrollment: 350
Study start: March 2004
Eligibility
Ages Eligible for Study: 45 Years and above, Genders Eligible for Study: Male
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
Location Information
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A1481217
Last Updated: September 1, 2005
Record first received: August 31, 2005
ClinicalTrials.gov Identifier: NCT00143221
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 1, 2005
Record first received: August 31, 2005
ClinicalTrials.gov Identifier: NCT00143221
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
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