Complementary and Alternative Medicine for Urological Symptoms(CAMUS)
Condition: Urological
Intervention: Saw Palmetto - first 24 weeks; Placebo - first 24 weeks; Saw Palmetto - weeks 24 - 48; Placebo - weeks 24 - 48; Saw Palmetto - weeks 48 - 72; Placebo - weeks 48 - 72
Intervention description: Participants will take one 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.; Participants will take one 320 mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.; Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.; Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a placebo for 24 weeks.; Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.; Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.
Intervention MeSH terms: Saw palmetto extract
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 369.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Serenoa repens; Urological symptoms; hyperplasia; BPH

Summary:

      The CAMUS trial will test Saw palmetto in about 369 men. Men who decide to be part of the
      CAMUS trial will be given one out of two possible treatments at random. One out of every two
      men would get an inactive placebo treatment. One out of every two men would get Saw palmetto
      pills.

      This kind of scientific study is the best way to find out if the plant extracts really work
      to prevent men with benign prostatic hyperplasia (BPH) from getting worse. During the study,
      men will not know which of the two treatments they are assigned to. They will be followed
      very closely by a study team every 12 weeks to see how they are doing. Men in the CAMUS trial
      will be studied over 72 weeks. Tests and all medications needed as part of the study will be
      provided at no charge to the participant. Participants will be responsible for all other
      costs not associated with the study tests and medications. All information on study
      participants will be held in the strictest confidence and no one would have access to patient
      information other than the required authorized health care and research personnel.
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for the study, potential participants must meet all of the following
        eligibility criteria:

          1. Male at least 45 years of age.

          2. Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml.

          3. AUA symptom score ≥ 8 and ≤ 24 at both screening visits.

          4. Voluntarily signed informed consent agreement prior to the performance of any study
             procedures.

        Exclusion Criteria:

        Potential participants that meet any of the following exclusion criteria will be excluded
        from the full-scale trial:

          1. Any prior invasive intervention for BPH.

          2. Phytotherapy for BPH or a 5-alpha reductase inhibitor within 3 months.

          3. Alpha blocker within one month.

          4. Reported allergic reaction to Serenoa repens.

          5. Taken phenylephrine, pseudoephedrine, tricyclic antidepressants, and anticholinergic
             or cholinergic medication within 4 weeks of the first screening visit, with the
             following exception: topical anticholinergic eye drops used for glaucoma.

          6. Taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic
             steroids within 6 months.

          7. Known clinically significant renal impairment (i.e., creatinine greater than 2.0
             mg/dl).

          8. Alanine aminotransferase(ALT)serum glutamic pyruvic transaminase(SGPT), aspartate
             aminotransferase(AST)serum glutamic oxaloacetic transaminase (SGOT) or
             gamma-glutamyltranspeptidase (GGT) value greater than 3 times the upper limit of
             normal in the clinical center lab at SV1.0; confirmed on a second measurement.

          9. Prothrombin time greater than 3 seconds above the upper limit of normal, or more than
             3 seconds above the control value in the clinical center at SV1.0; confirmed on a
             second measurement.

         10. Electrocardiogram (ECG) reading at the clinical center at SV1.0 suggesting active
             ischemia or recent myocardial infarction until appropriate consultation confirms the
             absence of an acute coronary syndrome.

         11. Prostate-specific antigen (PSA) level greater than 10 ng/ml at the first screening
             visit.

         12. Requires the daily use of a pad or device for incontinence, or International
             Continence Society male incontinence symptom (ICSmaleIS) score >14 at screening.

         13. Unstable medical condition within the past 3 months.

         14. History or current evidence of carcinoma of the prostate or bladder, pelvic radiation
             or surgery, urethral stricture, or prior surgery for bladder neck obstruction.

         15. Active urinary tract disease or has undergone cystoscopy or biopsy of the prostate
             within one month prior to the first screening visit or has an imminent need for
             urologic surgery.

         16. Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease
             or other neurological diseases known to affect bladder function.

         17. Documented bacterial prostatitis within the past year.

         18. Two documented independent urinary tract infections of any type in the past year.

         19. Known severe bleeding disorder or need for ongoing therapeutic anticoagulation with
             coumadin or heparin.

         20. Cancer, which is not considered cured (except basal cell or squamous cell carcinoma of
             the skin). A potential participant is considered cured if there has been no evidence
             of cancer within five years of randomization. A history of bladder cancer or prostate
             cancer is exclusionary whether the participant is considered cured or not.

         21. Unable to follow protocol directions due to organic brain or psychiatric disease.

         22. History of alcoholism or any other substance abuse, which, in the opinion of the
             investigator, would affect compliance with the protocol.

         23. Any serious medical condition likely to impede successful completion of the study.