The primary objective of this trial is to determine if two phytotherapies (Serenoa repens or Pygeum africanum) delay or prevent the progression of Benign Prostatic Hyperplasia (BPH).

Condition	Treatment or Intervention	Phase
Prostatic Hyperplasia	Drug: Serenoa repens  Drug: Pygeum africanum  Drug: Tamsulosin	Phase III

Further Study Details: 

Primary Outcomes: Time to clinical progression of BPH.
Expected Total Enrollment:  2860

Participants will be randomly assigned to one of the four treatments: extract of Serenoa repens, extract of Pygeum africanum, tamsulosin, or placebo. Participants will have clinic visits every four months for 4 years. The following assessments will be performed at study visits: a physical examination, a digital rectal examination, medical follow-up (new diagnoses, treatments, hospitalizations), urinalysis, vital signs, PSA, uroflow measurements, questionnaires related to prostate health, assessment of adverse events and medications. Blood chemistries and transrectal ultrasound (TRUS) will be performed on a subset of participants.

Ages Eligible for Study:  45 Years and above,  Genders Eligible for Study:  Male

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml
• American Urological Association symptom score between 8 and 24 at both screening visits

Regina Ryan      205-934-5165    regina.gay@ccc.uab.edu

California
      Kaiser Permanente Division of Research, Oakland,  California,  94612,  United States
Colorado
      University of Colorado Health Sciences Center, Aurora,  Colorado,  80045,  United States
Illinois
      Northwestern University Medical School, Chicago,  Illinois,  60611,  United States
Iowa
      University of Iowa, Iowa City,  Iowa,  52242,  United States
Maryland
      University of Maryland School of Medicine, Baltimore,  Maryland,  21201,  United States
Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  63110,  United States
New York
      New York University, New York,  New York,  10016,  United States
      Columbia University, New York,  New York,  10032,  United States
Texas
      University of Texas - Southwestern Medical Center, Dallas,  Texas,  75390,  United States
Canada, Ontario
      Queen's University, Kingston,  Ontario,  K7L 2V7,  Canada

Study ID Numbers:  DK063788-01
Record last reviewed:  November 2004
Last Updated:  November 24, 2004
Record first received:  November 17, 2004
ClinicalTrials.gov Identifier:  NCT00097136
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08