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

Chesapeake Urology Research Associates

Status and phase: Completed; Phase 3

Conditions: Lower Urinary Tract Symptoms; Erectile Dysfunction

Treatments: Drug: Alfuzosin; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00893113

CURA-RT-002

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 74 patients

Sex: Male

Ages: 30 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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74 participants in 2 patient groups, including a placebo group

Placebo, Then Alfuzosin

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Alfuzosin

Alfuzosin, Then Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Alfuzosin