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Sponsors and Collaborators: |
University of Alabama at Birmingham Cornell University New York University School of Medicine Kaiser Permanente Northwestern University Queen's University University of Colorado at Denver and Health Sciences Center University of Iowa University of Maryland University of Texas Washington University School of Medicine Yale University |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00603304 |
The CAMUS trial will test Saw palmetto in about 332 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 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.
Condition | Intervention | Phase |
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Urological Symptoms |
Drug: Saw Palmetto Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Complimentary and Alternative Medicine for Urological Symptoms (CAMUS) |
Estimated Enrollment: | 350 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Placebo Comparator
Treatment, Randomized, Double-blind, Placebo Controlled, Parallel Assignment, Efficacy Study
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Drug: Saw Palmetto
Drug: Saw Palmetto REGIMEN: Participants will be randomized to one of the treatment arms: Serenoa repens 320 mg once daily for 24 weeks followed by Serenoa repens 640 mg once daily for 24 weeks followed by Serenoa repens 960 mg once daily for 24 weeks. Placebo for 72 weeks. DURATION: Participants will continue on study treatment until they meet a protocol defined reason for treatment discontinuation or complete 72 weeks of follow-up at the assigned treatment. SAMPLE SIZE: 350 participants randomized in a 1:1 allocation to Serenoa repens or placebo. Arms: 2 , 2 Other Names: Serenoa repens (saw palmetto)
matching placebo intervention
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1: Active Comparator
Active and Placebo comparison
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Drug: Saw Palmetto
Drug: Saw Palmetto REGIMEN: Participants will be randomized to one of the treatment arms: Serenoa repens 320 mg once daily for 24 weeks followed by Serenoa repens 640 mg once daily for 24 weeks followed by Serenoa repens 960 mg once daily for 24 weeks. Placebo for 72 weeks. DURATION: Participants will continue on study treatment until they meet a protocol defined reason for treatment discontinuation or complete 72 weeks of follow-up at the assigned treatment. SAMPLE SIZE: 350 participants randomized in a 1:1 allocation to Serenoa repens or placebo. Arms: 2 , 2 Other Names: Serenoa repens (saw palmetto) Arms: 2 Other Names: Serenoa repens (saw palmetto) |
The CAMUS trial is studying the outcomes using herbal therapy for benign prostatic hyperplasia (BPH).
BPH is a common problem for older men. With BPH, the prostate grows larger. Over time, this growth can cause bothersome urinary symptoms. These symptoms can include frequent and/or urgent urination during the day or at night. Men with BPH can also have a weak urine stream, a stream that stops and starts, a feeling of not emptying the bladder all the way, and/or a need to strain to get urination started. BPH is NOT the same as prostate cancer.
A number of natural products (extracts of different plants) seem to be able to reduce the bothersome symptoms of BPH with very few side effects over a few months. One of the plant extracts comes from the dwarf palm tree (Saw palmetto). We do not know whether these plant extracts will reduce the symptoms of BPH over a longer period of treatment.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
To be eligible for the study, potential participants must meet all of the following eligibility criteria:
Exclusion Criteria:
Potential participants that meet any of the following exclusion criteria will be excluded from the full-scale trial:
Contact: Michael Barry, MD | 617-726-4106 | mbarry@partners.org |
Contact: Jeannette Y. Lee, PhD | 205-934-5875 | JYLee@uab.edu |
United States, California | |
Kaiser Permanente Division of Research | Recruiting |
Oakland, California, United States, 94612 | |
Contact: Study Coordinator, TBA 877-570-0010 avins@itsa.ucsf.edu | |
Principal Investigator: Andrew L. Avins, MD, MPH | |
United States, Colorado | |
University of Colorado | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Study Coordinator 720-848-1388 david.crawford@uchsc.edu | |
Principal Investigator: David Crawford, MD | |
United States, Connecticut | |
Yale University | Recruiting |
New Haven, Connecticut, United States, 06519 | |
Contact: Harris Foster, MD 203-785-2815 harris.foster@yale.edu | |
Principal Investigator: Harris E. Foster, MD | |
United States, Illinois | |
Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Study Coordinator, TBA 312-695-3813 K-mcvary@northwestern.edu | |
Principal Investigator: Kevin T. McVary, MD | |
United States, Iowa | |
University of Iowa | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Study Coordinator 319-384-5769 Karl-kredier@uiowa.edu | |
Principal Investigator: Karl J. Kreder, MD | |
United States, Maryland | |
University of Maryland | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Study Coordinator 410-328-7742 Mnaslund@smail.umaryland.edu | |
Principal Investigator: Michael J. Naslund, MD, MBA | |
United States, Missouri | |
Washington University | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Study Coordinator 314-362-8212 andrioleg@msnotes.wustl.edu | |
Principal Investigator: Gerald L. Andriole, MD | |
United States, New York | |
Cornell University | Recruiting |
New York, New York, United States, 10021 | |
Contact: Steven A. Kaplan, MD 212-746-4811 kaplans@med.cornell.edu | |
Principal Investigator: Steven A. Kaplan, MD | |
New York University | Recruiting |
New York, New York, United States, 10006 | |
Contact: TBA 646-825-6328 Andy.McCullough@nyumc.org | |
Principal Investigator: Andrew McCullough, MD | |
United States, Texas | |
University of Texas - Southwestern Medical Center | Recruiting |
Dallas, Texas, United States, 21201 | |
Contact: Allison Beaver 214-648-2941 Allison.Beaver@UTSouthwestern.edu | |
Principal Investigator: Claus Roehrborn, MD | |
Canada, Ontario | |
Queen's University | Recruiting |
Kingston, Ontario, Canada, K7L2V7 | |
Contact: Joe Downey 613-548-7832 downeyj@queensu.ca | |
Principal Investigator: J. Curtis Nickel, MD |
Study Chair: | Michael Barry, MD | Massachusetts General Hospital |
Principal Investigator: | Jeannette Y. Lee, PhD | The University of Alabama at Birmingham |
Responsible Party: | The University of Alabama at Birmingham ( Jeannette Y. Lee, PhD ) |
Study ID Numbers: | IRB: X021004002, NCI Grant # U01DK63788-05, Tracking # (UAB) 000175609 |
Study First Received: | December 20, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00603304 |
Health Authority: | United States: Food and Drug Administration |
Serenoa repens Urological symptoms hyperplasia BPH |
Hyperplasia Permixon |
Estrogen Receptor Modulators Androgen Antagonists Estrogen Antagonists Hormone Antagonists |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions |