Saw Palmetto Extract in Benign Prostatic Hyperplasia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00037154 |
Recruitment Status :
Completed
First Posted : May 17, 2002
Last Update Posted : January 14, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Benign Prostatic Hyperplasia | Drug: Saw Palmetto | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 224 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Saw Palmetto Extract In Benign Prostatic Hyperplasia |
Study Start Date : | August 1999 |
Study Completion Date : | December 2002 |


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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Eligibility Criteria:
- Participants must be men, aged 50 years or older with moderate-to-severe BPH.
- Participants must not have a history of prostate cancer, prior surgery on the prostate, kidney failure, or taking furosemide (Lasix), warfarin (Coumadin), or hormone medications. Individuals taking medicine for their BPH must stop them for one month (prazosin, terazosin (Hytrin), doxazosin (Cardura), tamsulosin (Flomax)) or six months (saw palmetto, finasteride (Proscar or Rogaine)) prior to entering the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037154
United States, California | |
Northern California Kaiser Permanente | |
Oakland, California, United States, 94611 | |
Veterans Affairs Medical Center | |
San Francisco, California, United States, 94121 |
Principal Investigator: | Andrew Avins, MD, MPH | Northern California Kaiser Permanente; University of California, San Francisco; San Francisco Veterans Affairs Medical Center | |
Study Director: | Stephen Bent, MD | University of California, San Francisco; San Francisco Veterans Affairs Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00037154 |
Other Study ID Numbers: |
5 R01 DK056199 (completed) |
First Posted: | May 17, 2002 Key Record Dates |
Last Update Posted: | January 14, 2010 |
Last Verified: | January 2010 |
Benign Prostatic Hyperplasia Herbal Therapies Complementary and Alternative Medicine Men's Health |
Prostatic Hyperplasia Hyperplasia Pathologic Processes Prostatic Diseases Genital Diseases, Male |
Genital Diseases Urogenital Diseases Male Urogenital Diseases Saw palmetto extract Urological Agents |