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Sponsors and Collaborators: |
Chesapeake Urology Research Associates Sanofi-Aventis |
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Information provided by: | Chesapeake Urology Research Associates |
ClinicalTrials.gov Identifier: | NCT00893113 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
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. |
Estimated Enrollment: | 60 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo: Placebo Comparator |
Drug: Alfuzosin
10 mg once daily
Drug: Alfuzosin
10 mg once daily
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Alfuzosin: Experimental |
Drug: Alfuzosin
10 mg once daily
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Ages Eligible for Study: | 30 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mary O'Conor, CCRC | 443-471-5740 | moconor@cua.md |
Contact: Virginia Michaels, CRC | 410-760-9400 | vmichaels@cua.md |
United States, Maryland | |
Chesapeake Urology Research Associates | |
Baltimore, Maryland, United States, 21204 | |
Chesapeake Urology Research Associates | |
Glen Burnie, Maryland, United States, 21061 | |
Chesapeake Urology Research Associates | |
Bel Air, Maryland, United States, 21014 | |
Chesapeake Urology Research Associates | |
Towson, Maryland, United States, 21204 | |
Chesapeake Urology Research Associates | |
Towson, Maryland, United States, 21204 | |
Chesapeake Urology Research Associates | |
Baltimore, Maryland, United States, 21207 |
Principal Investigator: | Ronald F Tutrone, MD | Chesapeake Urology Research Associates |
Responsible Party: | Chesapeake Urology Research Associates ( Ronald Tutrone, MD ) |
Study ID Numbers: | CURA-RT-002 |
Study First Received: | April 8, 2009 |
Last Updated: | May 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00893113 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Sexual Dysfunctions, Psychological Neurotransmitter Agents Alfuzosin Sexual Dysfunction, Physiological Adrenergic Agents Mental Disorders |
Adrenergic Antagonists Cardiovascular Agents Adrenergic alpha-Antagonists Antihypertensive Agents Genital Diseases, Male Erectile Dysfunction |
Sexual Dysfunctions, Psychological Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Adrenergic alpha-Antagonists Antihypertensive Agents Genital Diseases, Male |
Sexual and Gender Disorders Pharmacologic Actions Sexual Dysfunction, Physiological Alfuzosin Mental Disorders Therapeutic Uses Adrenergic Antagonists Erectile Dysfunction |