An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis

Phase

Condition

Urinary Tract Infections

Sexually Transmitted Diseases (Stds)

Prostate Disorders

Treatment

N/A

Clinical Study ID

NCT00402688

CR012103

Ages > 40
Male

Study Summary

The purpose of this study is to compare the safety and effectiveness of levofloxacin 750 mg for 2 weeks or 750 mg for 3 weeks, compared to levofloxacin 500 mg for 4 weeks in the treatment of chronic prostatitis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Males 40 years of age or older
A clinical diagnosis of chronic prostatitis as evidenced by the following twocriteria: 1. Clinical signs and symptoms of prostatitis including a soft, tenderprostate without noticeable nodularity with one or more of the following signs orsymptoms: painful or difficult urination, suprapubic discomfort, painful ejaculation,low back pain, perineal discomfort, urinary frequency, urinary urgency or hesitancy,decreased urinary stream, urinary retention, pain on digital rectal examination,perineal tenderness or pain, fever, chills. 2. A history of chronic prostatitis asdefined as: symptomatic prostatitis - a clinical diagnosis of prostatitis having beenmade for at least one previous episode that lasted four weeks, or two or more episodesduring the previous twelve months.

Exclusion

Exclusion Criteria:

Any condition which may interfere with the evaluation of study drug includingtransurethral prostatectomy within six months of enrollment, the presence of apermanent transurethral catheter or a history of cystostomy or nephrostomy
Taking hormone therapy
Known prostatic carcinoma
Allergy to levofloxacin, ofloxacin, ciprofloxacin, or other members of the quinoloneclass of antibacterials.

Study Design

November 01, 2006

September 30, 2008

Study Description

The optimal duration of treatment for chronic prostatitis remains unclear. Historically, therapy for chronic prostatitis with other classes of antibacterials resulted in poor outcomes and prolonged time taking the medication. Levofloxacin belongs to the quinolone class of antibacterials and has been used to treat chronic prostatitis with 500mg of levofloxacin taken orally once a day for 4 weeks. This multicenter, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance) study is designed to see if giving levofloxacin at a higher dose for shorter periods of time is safe and effective in treating chronic prostatitis. Safety analyses will involve the examination of the incidence, severity, and type of adverse events and changes in physical findings including vital signs and clinical laboratory tests. Patients will receive one of the following three dosing options: levofloxacin 750 mg orally administered once-a-day for 2 weeks followed by placebo once-a-day for two weeks for a total of 4 weeks, or levofloxacin 750 mg orally once-a-day for 3 weeks followed by placebo once-a-day for one week for a total of 4 weeks, or levofloxacin 500 mg orally once-a-day for 4 weeks.

Connect with a study center

Birmingham, Alabama
United States
Site Not Available
Homewood, Alabama
United States
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Anchorage, Alaska
United States
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Hot Springs, Arkansas
United States
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Fresno, California
United States
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San Diego, California
United States
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Denver, Colorado
United States
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New Britain, Connecticut
United States
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New Smyrna, Florida
United States
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Ocala, Florida
United States
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Orlando, Florida
United States
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Ormond Beach, Florida
United States
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Plantation, Florida
United States
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St Petersburg, Florida
United States
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Tallahassee, Florida
United States
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Tampa, Florida
United States
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Wellington, Florida
United States
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Columbus, Georgia
United States
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Roswell, Georgia
United States
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Jeffersonville, Indiana
United States
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Des Moines, Iowa
United States
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Shreveport, Louisiana
United States
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Greenbelt, Maryland
United States
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Saint Louis, Missouri
United States
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Las Vegas, Nevada
United States
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Marlton, New Jersey
United States
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Albuquerque, New Mexico
United States
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Garden City, New York
United States
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Kingston, New York
United States
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New York, New York
United States
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Orchard Park, New York
United States
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Poughkeepsie, New York
United States
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Staten Island, New York
United States
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Salisbury, North Carolina
United States
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Bethany, Oklahoma
United States
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Allentown, Pennsylvania
United States
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Bala Cynwyd, Pennsylvania
United States
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State College, Pennsylvania
United States
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