An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-10-31

Brief Summary

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The purpose of this study is to assess the effect of Alfuzosin in treating Erectile Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline in erectile function (EF) domain of International Index of Erectile Function (IIEF).

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Detailed Description

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This protocol is a placebo-controlled, double-blind, crossover trial. Patients will be screened and then randomized to Group A or Group B at a 1:1 ratio to receive a placebo tablet once daily or Alfuzosin (10 mg) daily for 12 weeks. Patients will then crossover with the original placebo group receiving Alfuzosin for 12 weeks and the original Alfuzosin group receiving placebo. At every visit the patients will complete an IIEF and an AUA symptom index.

Conditions

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Erectile Dysfunction Lower Urinary Tract Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo, Then Alfuzosin

Participants first received 1 Placebo tablet once daily for 12 weeks. Participants then received a 10 mg tablet of Alfuzosin daily for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Alfuzosin-matched One tablet once daily

Alfuzosin

Intervention Type DRUG

10 mg once daily

Alfuzosin, Then Placebo

Participants first received a 10 mg tablet of Alfuzosin once daily for 12 weeks. Participants then received 1 Placebo tablet once daily for 12 weeks.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Alfuzosin-matched One tablet once daily

Alfuzosin

Intervention Type DRUG

10 mg once daily

Interventions

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Placebo

Alfuzosin-matched One tablet once daily

Intervention Type DRUG

Alfuzosin

10 mg once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male, 30-69 years of age
* Has mild to moderate Erectile Dysfunction with a score \< 25 on EF domain in IIEF
* AUA score of less than or equal to 14
* Negative urinalysis with no evidence of a Urinary Tract Infection

Exclusion Criteria

* Blood pressure \< 90/50 or \> 170/110
* Neurological disorder (MS, SCI, CVA, Parkinson's disease, ALS)
* Diabetes Mellitus
* History of PSA \> 10
* History of confirmed or suspected prostate cancer
* History of Moderate/Severe Hepatic Insufficiency defined as \> 2X ULN
* On Alpha Blocker or PDE 5 inhibitor within 2 weeks of randomization
* Receive treatment with other investigational agents within 30 days prior to enrollment

Minimum Eligible Age

30 Years

Maximum Eligible Age

69 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No