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

NCT00893113 | Completed Phase 3 Results DMC

• 1 other identifier: CURA-RT-002
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Erectile Dysfunction; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Erectile Function Domain of the International Index of Erectile Function

  The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The Erectile Function (EF) domain of the IIEF is used to assess specific key components of ED including ability to achieve penetration and ability to maintain erection sufficient for satisfactory sexual performance. A score of 0-5 is awarded to each question of the IIEF. The EF domain pertains to questions 1, 2, 3, 4, 5, and 15. Scores are totaled and ranges are assigned to results. In the EF domain, a score of 0-30 is possible. The EF scores can be interpreted as follows: 0-6 severe dysfunction, 7-12 moderate dysfunction, 13-18 mild to moderate dysfunction, 19-24 mild dysfunction, and 25-30 no dysfunction.

  Baseline and 12 Weeks

Secondary Outcomes (2)

• Changes in American Urological Association (AUA) Symptom Index

  Baseline and 12 Weeks

• Change in Total International Index of Erectile Function (IIEF) Score

  Baseline and 12 Weeks

Study Arms (2)

Placebo, Then Alfuzosin

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Alfuzosin

Alfuzosin, Then Placebo

EXPERIMENTAL

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.

Drug: Placebo; Drug: Alfuzosin

Interventions

Placebo DRUG

Alfuzosin-matched One tablet once daily

Alfuzosin, Then Placebo; Placebo, Then Alfuzosin

Alfuzosin DRUG

10 mg once daily

Alfuzosin, Then Placebo; Placebo, Then Alfuzosin

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chesapeake Urology Research Associates: lead
• Sanofi: collaborator

Study Sites (4)

Chesapeake Urology Research Associates

Baltimore, Maryland, 21204, United States

Location

Chesapeake Urology Research Associates

Baltimore, Maryland, 21237, United States

Location

Chesapeake Urology Research Associates

Glen Burnie, Maryland, 21061, United States

Location

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction; Lower Urinary Tract Symptoms

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Data compiled in this study is unable to neither prove nor disprove the objectives set. Placebo effect and recall bias may affect results. Regular sexual interaction and prior exposure to Alfuzosin were not evaluated.

Results Point of Contact

• Title: Ronald Tutrone, MD
• Organization: Chesapeake Urology Research Associates

hthomas@cua.md

443.471.5742

Study Officials

• Ronald F Tutrone, MD

  Chesapeake Urology Research Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: May 5, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 9, 2018
• Results First Posted: August 1, 2016

Record last verified: 2018-02

Locations

US (4)