An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis
An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis
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.
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.
Inclusion Criteria:

 -  Males 40 years of age or older

 -  A clinical diagnosis of chronic prostatitis as evidenced by the following two
 criteria: 1. Clinical signs and symptoms of prostatitis including a soft, tender
 prostate without noticeable nodularity with one or more of the following signs or
 symptoms: 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 as
 defined as: symptomatic prostatitis - a clinical diagnosis of prostatitis having been
 made for at least one previous episode that lasted four weeks, or two or more episodes
 during the previous twelve months.

 Exclusion Criteria:

 -  Any condition which may interfere with the evaluation of study drug including
 transurethral prostatectomy within six months of enrollment, the presence of a
 permanent 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 quinolone
 class of antibacterials.