This study will investigate the efficacy and safety of treatment with dutasteride (Avodart) and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.

Condition	Treatment or Intervention	Phase
Benign Prostatic Hyperplasia	Drug: Avodart  Drug: Tamsulosin	Phase III

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Male

Criteria

Incusion Criteria:

• Informed consent
• Diagnosis of BPH
• Prostate specific antigen (PSA) >1.5ng/ml
• Prostate volume by TRUS >30cc
• Urine flow rate of >5 and < 15ml for two voids
• Willing and able to participate for 4 years

Exclusion Criteria:

• PSA >10.0ng/ml at screening
• No previous prostatic surgery
• History of acute urinary retention (AUR) within 3 months of screening
• Post voided volume of > 250ml
• Use of alpha blockers (Flomax, Hytrin, Cardura etc) within 2 weeks of screening
• Use of 5-alpha reductase inhibitors (Proscar, or Propecia) with 6 months
• Use of dutasteride (Avodart) within 12 months
• Concurrent use of steroids

Alabama
      Hoover,  Alabama,  35216,  United States; Recruiting
      Birmingham,  Alabama,  35234,  United States; Recruiting
      Birmingham,  Alabama,  35242,  United States; Recruiting
Alaska
      Anchorage,  Alaska,  99508,  United States; Recruiting
Arizona
      Phoenix,  Arizona,  85018,  United States; Recruiting
California
      Los Angeles,  California,  90017,  United States; Recruiting
      Beverly Hills,  California,  90212,  United States; Recruiting
      Torrance,  California,  90505,  United States; Recruiting
      Glendora,  California,  91741,  United States; Recruiting
      Vista,  California,  92084,  United States; Recruiting
      San Diego,  California,  92103,  United States; Recruiting
      San Diego,  California,  92103,  United States; Recruiting
      Irvine,  California,  92618,  United States; Recruiting
      Concord,  California,  94520,  United States; Recruiting
      Carmichael,  California,  95608,  United States; Recruiting
Florida
      St. Augustine,  Florida,  32086,  United States; Recruiting
      Daytona Beach,  Florida,  32114,  United States; Recruiting
      New Smyrna Beach,  Florida,  32168,  United States; Recruiting
      Tallahassee,  Florida,  32308,  United States; Recruiting
      Pensacola,  Florida,  32503,  United States; Recruiting
      Orange City,  Florida,  32763,  United States; Recruiting
      Coral Gables,  Florida,  33134,  United States; Recruiting
      Miami,  Florida,  33156,  United States; Recruiting
      Pinecrest,  Florida,  33156,  United States; Recruiting
      Aventura,  Florida,  33180,  United States; Recruiting
      West Palm Beach,  Florida,  33407,  United States; Recruiting
      Wellington,  Florida,  33414,  United States; Recruiting
      Lake Worth,  Florida,  33461,  United States; Recruiting
      St. Petersburg,  Florida,  33702,  United States; Recruiting
      St. Petersburg,  Florida,  33710,  United States; Recruiting
      Ocala,  Florida,  34471,  United States; Recruiting
      Spring Hill,  Florida,  34608,  United States; Recruiting
      Stuart,  Florida,  34996,  United States; Recruiting
      Panama City,  Florida,  91402,  United States; Recruiting
Georgia
      Decatur,  Georgia,  30033,  United States; Recruiting
      Atlanta,  Georgia,  30342,  United States; Recruiting
      Blue Ridge,  Georgia,  30513,  United States; Recruiting
      Calhoun,  Georgia,  30701,  United States; Recruiting
Idaho
      Meridian,  Idaho,  83642,  United States; Recruiting
Illinois
      Wheaton,  Illinois,  60187,  United States; Recruiting
      Peoria,  Illinois,  61614,  United States; Recruiting
      Peoria,  Illinois,  61614,  United States; Recruiting
      Belleville,  Illinois,  62220,  United States; Recruiting
Indiana
      South Bend,  Indiana,  46601,  United States; Recruiting
      Evansville,  Indiana,  47714,  United States; Recruiting
      Evansville,  Indiana,  47714,  United States; Recruiting
Iowa
      Des Moines,  Iowa,  50309,  United States; Recruiting
Kansas
      Wichita,  Kansas,  67207,  United States; Recruiting
Kentucky
      Murray,  Kentucky,  42071,  United States; Recruiting
Maryland
      Laurel,  Maryland,  20724,  United States; Recruiting
Minnesota
      Minneapolis,  Minnesota,  55417,  United States; Recruiting
Mississippi
      Picayune,  Mississippi,  39466,  United States; Recruiting
Missouri
      Kansas City,  Missouri,  64114,  United States; Recruiting
Montana
      Missoula,  Montana,  59801,  United States; Recruiting
New Jersey
      Hillsborough,  New Jersey,  08844,  United States; Recruiting
New Mexico
      Albuquerque,  New Mexico,  87108,  United States; Recruiting
New York
      Garden City,  New York,  11530,  United States; Recruiting
      Bay Shore,  New York,  11706,  United States; Recruiting
      Lewiston,  New York,  14092,  United States; Recruiting
North Carolina
      Asheboro,  North Carolina,  27203,  United States; Recruiting
      Cary,  North Carolina,  27511,  United States; Recruiting
      Fayetteville,  North Carolina,  28304,  United States; Recruiting
      Morehead City,  North Carolina,  28557,  United States; Recruiting
Ohio
      Columbus,  Ohio,  43212,  United States; Recruiting
      Cincinnati,  Ohio,  45236,  United States; Recruiting
      Bellbrook,  Ohio,  45305,  United States; Recruiting
Oregon
      Portland,  Oregon,  97201,  United States; Recruiting
Pennsylvania
      Fleetwood,  Pennsylvania,  19522,  United States; Recruiting
Rhode Island
      Providence,  Rhode Island,  02904,  United States; Recruiting
Tennessee
      Nashville,  Tennessee,  37203,  United States; Recruiting
Texas
      Dallas,  Texas,  75230,  United States; Recruiting
      Dallas,  Texas,  75234,  United States; Recruiting
      Athens,  Texas,  75751,  United States; Recruiting
      Ft. Worth,  Texas,  76107,  United States; Recruiting
      Houston,  Texas,  77024,  United States; Recruiting
      Houston,  Texas,  77024,  United States; Recruiting
      New Braunfels,  Texas,  78130,  United States; Recruiting
      San Antonio,  Texas,  78229,  United States; Recruiting
Virginia
      Alexandria,  Virginia,  22304,  United States; Recruiting
Washington
      Bellevue,  Washington,  98004,  United States; Recruiting
      Seattle,  Washington,  98104,  United States; Recruiting
      Tacoma,  Washington,  98405,  United States; Recruiting
      Spokane,  Washington,  99204,  United States; Recruiting
West Virginia
      Henderson,  West Virginia,  89014,  United States; Recruiting
      Henderson,  West Virginia,  89014,  United States; Recruiting

Study ID Numbers:  ARI40005
Record last reviewed:  January 2005
Last Updated:  January 4, 2005
Record first received:  August 24, 2004
ClinicalTrials.gov Identifier:  NCT00090103
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08