Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Chesapeake Urology Research Associates
ClinicalTrials.gov Identifier:
NCT00893113
First received: April 8, 2009
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to assess the effect of Alfuzosin in treating Erectile Dysfunction in Men that have lower urinary tract symptoms.


Condition Intervention Phase
Erectile Dysfunction
Lower Urinary Tract Symptoms
Drug: Alfuzosin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Double Blind, Placebo-COntrolled, Crossover Study to Evaluate the Efficacy of Alfuzosin in Treating Men With ED and Mild LUTS.

Resource links provided by NLM:


Further study details as provided by Chesapeake Urology Research Associates:

Primary Outcome Measures:
  • Change from baseline EF domain of the IIEF [ Time Frame: Week 1, Week 12, Week 24, ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: June 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Alfuzosin
10 mg once daily
Drug: Alfuzosin
10 mg once daily
Experimental: Alfuzosin Drug: Alfuzosin
10 mg once daily

  Eligibility

Ages Eligible for Study:   30 Years to 69 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Has mild to moderate erectile Dysfunction
  • Negative urinalysis with no evidence of a Urinary Tract Infection

Exclusion Criteria:

  • Diabetes Mellitus
  • Neurological Disorders
  • Confirmed or suspected Prostate Cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893113

Locations
United States, Maryland
Chesapeake Urology Research Associates
Baltimore, Maryland, United States, 21204
Chesapeake Urology Research Associates
Baltimore, Maryland, United States, 21237
Chesapeake Urology Research Associates
Glen Burnie, Maryland, United States, 21061
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
Sponsors and Collaborators
Chesapeake Urology Research Associates
Sanofi
Investigators
Principal Investigator: Ronald F Tutrone, MD Chesapeake Urology Research Associates
  More Information

No publications provided

Responsible Party: Chesapeake Urology Research Associates
ClinicalTrials.gov Identifier: NCT00893113     History of Changes
Other Study ID Numbers: CURA-RT-002
Study First Received: April 8, 2009
Last Updated: April 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Erectile Dysfunction
Lower Urinary Tract Symptoms
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Signs and Symptoms
Urological Manifestations
Alfuzosin
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 27, 2014