| ID | Type | Description | Link |
|---|---|---|---|
| U01DK063788 | U.S. NIH Grant/Contract | View source | |
| Tracking # (UAB) 000175609 | Other Identifier | Institutional Tracking number for OGCA |
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| Name | Class |
|---|---|
| Office of Dietary Supplements (ODS) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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). The investigators do not know whether these plant extracts will reduce the symptoms of BPH over a longer period of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will take one 320 mg placebo gelcap daily for 24 weeks one gelcap); followed by 640 mg daily for 24 weeks (two gelcaps) followed by 960 mg daily for 24 weeks (three gelcaps). |
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| Saw Palmetto | Active Comparator | Extract of Serenoa Repens 320 mg once daily for 24 weeks (one gelcap); followed by 640 mg daily for 24 weeks (two gelcaps) followed by 960 mg daily for 24 weeks (three gelcaps). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saw Palmetto - first 24 weeks | Drug | Participants will take one 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants. | The primary outcome was the mean difference in the AUA Symptom Score between baseline and 72 weeks between the saw palmetto and placebo groups. The AUA Symptom Score index is a seven item questionnaire assessing the frequency of lower urinary tract symptoms (LUTS). The questions are scored on a scale of zero to five, with zero being never, one to four being one to four accordingly, and five equaling five or more times. A Symptom Index is determined by adding the scores. The lowest possible score is 0 and the highest possible score is 35, which would represent the highest level of pain and discomfort. | Baseline to 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Global Assessments of Improvement and Satisfaction at End of Study. | Participants' global assessments of improvement and satisfaction at the end of the study. Likert scales were transformed to a 0 - 100 scale. The lowest possible score is 0 and the highest possible score is 100, which would reflect better outcomes. | Baseline to 72 weeks |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Barry, MD | Massachusetts General Hospital | Study Chair |
| Alan Cantor, PhD | The University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Division of Research | Oakland | California | 94612 | United States | ||
| University of Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20007408 | Background | Lee J, Andriole G, Avins A, Crawford ED, Foster H, Kaplan S, Kreder K, Kusek J, McCullough A, McVary K, Meleth S, Naslund M, Nickel JC, Nyberg L, Roehrborn C, Dale Williams O, Barry M. Redesigning a large-scale clinical trial in response to negative external trial results: the CAMUS study of phytotherapy for benign prostatic hyperplasia. Clin Trials. 2009 Dec;6(6):628-36. doi: 10.1177/1740774509352199. Epub 2009 Dec 9. | |
| 21554128 | Background |
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A total of 1032 men were prescreened for Complementary and Alternative Medicine for Urological Symptoms (CAMUS), usually by telephone; interested and preliminary eligible men were scheduled for a first screening visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Saw Palmetto | Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Cornell University | OTHER |
| New York University | OTHER |
| Kaiser Permanente | OTHER |
| Northwestern University | OTHER |
| Queen's University | OTHER |
| University of Colorado, Denver | OTHER |
| University of Iowa | OTHER |
| University of Maryland | OTHER |
| University of Texas | OTHER |
| Washington University School of Medicine | OTHER |
| Yale University | OTHER |
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| Placebo - first 24 weeks | Drug | Participants will take one 320 mg chocolate-colored soft gelcaps containing a placebo for 24 weeks. |
|
| Saw Palmetto - weeks 24 - 48 | Drug | Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks. |
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| Placebo - weeks 24 - 48 | Drug | Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a placebo for 24 weeks. |
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| Saw Palmetto - weeks 48 - 72 | Drug | Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks. |
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| Placebo - weeks 48 - 72 | Drug | Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a placebo for 24 weeks. |
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| Benign Prostate Hyperplasia (BPH) Impact Index Score | The mean difference in the BPH Impact Index score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The BPH Index Score is a self administered 4 item index. Three questions are scored on a scale from 0 to 3, with zero being none, one being only a little, two being some, and three being a lot. One question is scored on a scale from 0 to 4, with zero being none of the time, one being a little of the time, two being some of the time, three being most of the time, and four being all of the time. The lowest possible score is 0 and the highest possible score is 13, which would represent the greatest dysfunction. | Baseline to 72 weeks |
| International Prostate Symptom Score Quality of Life (IPSS QOL) Score | The mean difference in the IPSS Quality-of-Life Question from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The IPSS Quality-of-Life Question is an additional question to the AUA Symptom Score. The self administered question is scored on a scale from 0 to 6, with zero being delighted, one being pleased, two being mostly satisfied, three being mixed-about equally satisfied and dissatisfied, four being mostly dissatisfied, five being unhappy, and six being terrible. The lowest possible score is 0 and the highest possible score is 6, which would represent the greatest dysfunction. | Baseline to 72 weeks |
| American Urological Association(AUA) Nocturia Item | The mean difference in the nocturia item of the AUA Symptom Score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The nocturia item is a self administered question from the AUA Symptom Score Index that assesses the number of times a participant typically gets up to urinate from the time he goes to bed at night until the time he gets up in the morning. The question is scored on a scale of zero to five, with zero being none, one being one time, two being two times, three being three times, four being four times, and five being five or more times. The lowest possible score is 0 and the highest possible score is 5, which would represent the highest level dysfunction. | Baseline to 72 weeks |
| Peak Uroflow | The mean difference in the participants' peak uroflow from baseline to 72 weeks in the modified intention to treat analysis. The peak uroflow was measured in milliliters/seconds. The higher units indicated greater dysfunction. | Baseline to 72 weeks |
| Post-void Residual | The mean difference in the participants' post-void residual from baseline to 72 weeks in the modified intention to treat analysis. The post-void residual was measured in milliliters. The higher units indicated greater dysfunction. | Baseline to 72 weeks |
| Prostate Specific Antigen (PSA) Level | The mean difference in the PSA level from baseline to 72 weeks in the modified intention to treat analysis. The PSA level was measured in nanograms/milliliters. The higher units indicated greater dysfunction. | Baseline to 72 weeks |
| International Index of Erectile Function (IIEF)Scale Score. | The mean difference in the IIEF score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The IIEF is a multidimensional scale for assessment of erectile dysfunction. The six item self administered questionnaire is scored on a scale from 0 to 5, with zero being no sexual activity, one being never or almost never, two being a few times (much less than half the time), three being sometimes (much less than half the time), four being most times (much more than half the time), and five being always or almost always. The lowest possible score is 0 and the highest possible score is 30, which represents less dysfunction. | Baseline to 72 weeks |
| Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score. | The mean difference in the MSHQ-EjD from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The MSHQ-EjD scale is used for the assessment ejaculatory dysfunction (EjD). The MSHQ-EjD consists of four self administered questions. Three of the items are scored on a scale from 0 to 5, with zero being all the time, one being most of the time, two being some of the time, three being a little of the time, four being none of the time, and five being no sexual activity. The fourth item is scored on a scale of 1 - 5, with one being not at all bothered, two being a little bit bothered, three being moderately bothered, four being very bothered, and five being extremely bothered. The lowest possible score is 0 and the highest possible score is 20, which represents the highest level of dysfunction. | Baseline to 72 weeks. |
| International Continence Society Male Incontinence Symptom (ICSmale IS) Score | The mean difference in the ICSmaleIS score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The six item self administered questionnaire is scored on a scale from 0 to 4, with zero being never, one being occasionally, two being sometimes, three being most of the time, and four being all of the time. The lowest possible is 0 and the highest possible score is 24, which represents the the highest level of dysfunction. | Baseline to 72 weeks |
| Jenkins Sleep Scale Score | The mean difference in the Jenkins Sleep Dysfunction score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. Jenkins Sleep Dysfunction score is used to assess sleep dysfunction. The four item self administered questionnaire is scored on a scale from 0 to 5, with zero being not at all, one being 1 -3 days, two being 4 - 7 days, three being 8 - 14 days, four being 15 - 21 days, and five being 22 - 31 days. The lowest possible score is 0 and the highest possible score is 20, which represents the highest level of dysfunction. | Baseline to 72 weeks |
| NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale | The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale is a four item self administered questionnaire. Three of the four items are scored on a scale from 0 - 1, with zero being no and one being yes. The fourth item is scored on a scale from 0 - 10, with zero being no pain and ten being pain as bad as you can imagine. The lowest possible score is 0 and the highest possible score is 21, which represents the highest level of pain. | Baseline to 72 weeks |
| NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale | The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary symptom scale from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary symptom scale consists of two self administered questions. The questions are scored on a scale from 0 - 5, with zero being not at all, one being less than 1 time in 5, two being less than half the time, three being about half the time, four being more than half the time, and five being almost always. The lowest possible score is 0 and the highest possible score is 10, which represents the highest level of dysfunction. | Baseline to 72 weeks |
| NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale | The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL) scale from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL) scale consists of three self administered questions. Two of the questions are scored on a scale of 0 - 3, with zero being none, one being only a little, two being some, and three being a lot. The third question is scored on a scale of 0 -6, with zero being delighted, one being pleased, two being mostly satisfied, three being mixed (equally satisfied and dissatisfied), four being mostly dissatisfied, five being unhappy, and six being terrible. The lowest possible score is 0 and the highest possible score is 12, which represents the highest level of dysfunction. | Baseline to 72 weeks |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Yale University | New Haven | Connecticut | 06519 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| New York University | New York | New York | 10006 | United States |
| Cornell University | New York | New York | 10021 | United States |
| University of Texas - Southwestern Medical Center | Dallas | Texas | 21201 | United States |
| Queen's University | Kingston | Ontario | K7L2V7 | Canada |
| Lee JY, Foster HE Jr, McVary KT, Meleth S, Stavris K, Downey J, Kusek JW. Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia. J Altern Complement Med. 2011 May;17(5):469-72. doi: 10.1089/acm.2010.0300. Epub 2011 May 9. |
| 21741692 | Result | Barry MJ, Avins AL, Meleth S; Complementary and Alternative Medicine for Urological Symptoms Study Group. Performance of the American Urological Association Symptom Index with and without an additional urge incontinence item. Urology. 2011 Sep;78(3):550-4. doi: 10.1016/j.urology.2011.04.017. Epub 2011 Jul 8. |
| 21497839 | Result | Helfand BT, McVary KT, Meleth S, Sharp V, Foster H, Naslund M, Williams OD; CAMUS Study Group. The relationship between lower urinary tract symptom severity and sleep disturbance in the CAMUS trial. J Urol. 2011 Jun;185(6):2223-8. doi: 10.1016/j.juro.2011.02.012. Epub 2011 Apr 17. |
| 21954478 | Result | Barry MJ, Meleth S, Lee JY, Kreder KJ, Avins AL, Nickel JC, Roehrborn CG, Crawford ED, Foster HE Jr, Kaplan SA, McCullough A, Andriole GL, Naslund MJ, Williams OD, Kusek JW, Meyers CM, Betz JM, Cantor A, McVary KT; Complementary and Alternative Medicine for Urological Symptoms (CAMUS) Study Group. Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial. JAMA. 2011 Sep 28;306(12):1344-51. doi: 10.1001/jama.2011.1364. |
| 23083656 | Derived | Helfand BT, Lee JY, Sharp V, Foster H, Naslund M, Williams OD, McVary KT; CAMUS Study Group. Associations between improvements in lower urinary tract symptoms and sleep disturbance over time in the CAMUS trial. J Urol. 2012 Dec;188(6):2288-93. doi: 10.1016/j.juro.2012.07.104. Epub 2012 Oct 22. |
Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Saw Palmetto | Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks. |
| BG001 | Placebo | Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants. | The primary outcome was the mean difference in the AUA Symptom Score between baseline and 72 weeks between the saw palmetto and placebo groups. The AUA Symptom Score index is a seven item questionnaire assessing the frequency of lower urinary tract symptoms (LUTS). The questions are scored on a scale of zero to five, with zero being never, one to four being one to four accordingly, and five equaling five or more times. A Symptom Index is determined by adding the scores. The lowest possible score is 0 and the highest possible score is 35, which would represent the highest level of pain and discomfort. | The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 72 weeks |
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| Secondary | Participants Global Assessments of Improvement and Satisfaction at End of Study. | Participants' global assessments of improvement and satisfaction at the end of the study. Likert scales were transformed to a 0 - 100 scale. The lowest possible score is 0 and the highest possible score is 100, which would reflect better outcomes. | The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 72 weeks |
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| Secondary | Benign Prostate Hyperplasia (BPH) Impact Index Score | The mean difference in the BPH Impact Index score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The BPH Index Score is a self administered 4 item index. Three questions are scored on a scale from 0 to 3, with zero being none, one being only a little, two being some, and three being a lot. One question is scored on a scale from 0 to 4, with zero being none of the time, one being a little of the time, two being some of the time, three being most of the time, and four being all of the time. The lowest possible score is 0 and the highest possible score is 13, which would represent the greatest dysfunction. | The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 72 weeks |
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| Secondary | International Prostate Symptom Score Quality of Life (IPSS QOL) Score | The mean difference in the IPSS Quality-of-Life Question from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The IPSS Quality-of-Life Question is an additional question to the AUA Symptom Score. The self administered question is scored on a scale from 0 to 6, with zero being delighted, one being pleased, two being mostly satisfied, three being mixed-about equally satisfied and dissatisfied, four being mostly dissatisfied, five being unhappy, and six being terrible. The lowest possible score is 0 and the highest possible score is 6, which would represent the greatest dysfunction. | The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 72 weeks |
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| Secondary | American Urological Association(AUA) Nocturia Item | The mean difference in the nocturia item of the AUA Symptom Score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The nocturia item is a self administered question from the AUA Symptom Score Index that assesses the number of times a participant typically gets up to urinate from the time he goes to bed at night until the time he gets up in the morning. The question is scored on a scale of zero to five, with zero being none, one being one time, two being two times, three being three times, four being four times, and five being five or more times. The lowest possible score is 0 and the highest possible score is 5, which would represent the highest level dysfunction. | The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 72 weeks |
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| Secondary | Peak Uroflow | The mean difference in the participants' peak uroflow from baseline to 72 weeks in the modified intention to treat analysis. The peak uroflow was measured in milliliters/seconds. The higher units indicated greater dysfunction. | The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement. | Posted | Mean | 95% Confidence Interval | mL/sec | Baseline to 72 weeks |
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| Secondary | Post-void Residual | The mean difference in the participants' post-void residual from baseline to 72 weeks in the modified intention to treat analysis. The post-void residual was measured in milliliters. The higher units indicated greater dysfunction. | The analysis population was determined by the number of participants that were randomized and included in the modified intention to treat analyses. | Posted | Mean | 95% Confidence Interval | mL | Baseline to 72 weeks |
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| Secondary | Prostate Specific Antigen (PSA) Level | The mean difference in the PSA level from baseline to 72 weeks in the modified intention to treat analysis. The PSA level was measured in nanograms/milliliters. The higher units indicated greater dysfunction. | The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement. | Posted | Mean | 95% Confidence Interval | ng/mL | Baseline to 72 weeks |
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| Secondary | International Index of Erectile Function (IIEF)Scale Score. | The mean difference in the IIEF score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The IIEF is a multidimensional scale for assessment of erectile dysfunction. The six item self administered questionnaire is scored on a scale from 0 to 5, with zero being no sexual activity, one being never or almost never, two being a few times (much less than half the time), three being sometimes (much less than half the time), four being most times (much more than half the time), and five being always or almost always. The lowest possible score is 0 and the highest possible score is 30, which represents less dysfunction. | The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 72 weeks |
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| Secondary | Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score. | The mean difference in the MSHQ-EjD from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The MSHQ-EjD scale is used for the assessment ejaculatory dysfunction (EjD). The MSHQ-EjD consists of four self administered questions. Three of the items are scored on a scale from 0 to 5, with zero being all the time, one being most of the time, two being some of the time, three being a little of the time, four being none of the time, and five being no sexual activity. The fourth item is scored on a scale of 1 - 5, with one being not at all bothered, two being a little bit bothered, three being moderately bothered, four being very bothered, and five being extremely bothered. The lowest possible score is 0 and the highest possible score is 20, which represents the highest level of dysfunction. | The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 72 weeks. |
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| Secondary | International Continence Society Male Incontinence Symptom (ICSmale IS) Score | The mean difference in the ICSmaleIS score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The six item self administered questionnaire is scored on a scale from 0 to 4, with zero being never, one being occasionally, two being sometimes, three being most of the time, and four being all of the time. The lowest possible is 0 and the highest possible score is 24, which represents the the highest level of dysfunction. | The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 72 weeks |
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| Secondary | Jenkins Sleep Scale Score | The mean difference in the Jenkins Sleep Dysfunction score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. Jenkins Sleep Dysfunction score is used to assess sleep dysfunction. The four item self administered questionnaire is scored on a scale from 0 to 5, with zero being not at all, one being 1 -3 days, two being 4 - 7 days, three being 8 - 14 days, four being 15 - 21 days, and five being 22 - 31 days. The lowest possible score is 0 and the highest possible score is 20, which represents the highest level of dysfunction. | The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 72 weeks |
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| Secondary | NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale | The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale is a four item self administered questionnaire. Three of the four items are scored on a scale from 0 - 1, with zero being no and one being yes. The fourth item is scored on a scale from 0 - 10, with zero being no pain and ten being pain as bad as you can imagine. The lowest possible score is 0 and the highest possible score is 21, which represents the highest level of pain. | The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 72 weeks |
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| Secondary | NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale | The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary symptom scale from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary symptom scale consists of two self administered questions. The questions are scored on a scale from 0 - 5, with zero being not at all, one being less than 1 time in 5, two being less than half the time, three being about half the time, four being more than half the time, and five being almost always. The lowest possible score is 0 and the highest possible score is 10, which represents the highest level of dysfunction. | The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 72 weeks |
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| Secondary | NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale | The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL) scale from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL) scale consists of three self administered questions. Two of the questions are scored on a scale of 0 - 3, with zero being none, one being only a little, two being some, and three being a lot. The third question is scored on a scale of 0 -6, with zero being delighted, one being pleased, two being mostly satisfied, three being mixed (equally satisfied and dissatisfied), four being mostly dissatisfied, five being unhappy, and six being terrible. The lowest possible score is 0 and the highest possible score is 12, which represents the highest level of dysfunction. | The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 72 weeks |
|
Collected over 72 weeks
The number of participants at risk was determined by the number of participants that were randomized and included in the modified intention to treat analyses.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saw Palmetto | One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks. | 18 | 176 | 138 | 176 | ||
| EG001 | Placebo | One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks. | 17 | 181 | 139 | 181 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendectomy for appendicitis | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Appendectomy for ruptured appendix | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Automobile accident with multiple injuries | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Back surgery for a lumbar spinal connective tissue cyst | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Bacterial epididymitis requiring intravenous antibiotics | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Cerebellar stroke | Nervous system disorders | Non-systematic Assessment |
| ||
| Colon resection for a polyp | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Elective knee replacement | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Elective knee replacement | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Elective plastic surgery | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Elective repair of abdominal aortic aneurysm | Vascular disorders | Non-systematic Assessment |
| ||
| Elective tonsillectomy and deviated nasal septum repair | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Episode of atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Gross hematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hospitalized after pacemaker insertion | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Hospitalized for abdominal pain, underwent laparascopic cholecystectomy | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Hospitalized for cellulitis of the elbow, required intravenous antibiotics | Infections and infestations | Non-systematic Assessment |
| ||
| Hospitalized for chest pain | General disorders | Non-systematic Assessment |
| ||
| Hospitalized for chest pain due to coronary artery disease, underwent revascularization | Cardiac disorders | Non-systematic Assessment |
| ||
| Hospitalized for chest pain that proved noncardiac after the study | General disorders | Non-systematic Assessment |
| ||
| Hospitalized for diverticulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Hospitalized for hypotension due to pneumonia and chronic kidney disease | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hospitalized for knee pain secondary to torn vastus lateralis muscle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Hospitalized for pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Hospitalized for radioactive iodine treatment for thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Inferior wall myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Lower gastointestinal diverticular bleeding | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Mestatic recurrent follicular thyroid carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Pancreatic Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Sepsis secondary to a pelvic fracture | Infections and infestations | Non-systematic Assessment |
| ||
| Severe Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Small bowel obstruction requiring laparoscopy lysis of adhesions | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Syncope with transient high grade atrioventricular block | Nervous system disorders | Non-systematic Assessment |
| ||
| Upper gastrointestinal bleeding requiring transfusion | Gastrointestinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Frost bite to bronchial tubes | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Increase mucus | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Strep Throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sinus Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sneezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Post Nasal Drip | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pre-Existing Lower Back Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Tonsilectomy and Deviated Septum Repair | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Knee Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Gout | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Foot Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Tendonitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Hip Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Shoulder Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Elbow Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Broken Tooth | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Chest Discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bursitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Cyst | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Osteoporosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Hernia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Facial Edema | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| C-Spine Degenerative Disease | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bruised Ribs/Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Flank Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Joint Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Fore Arm Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Lump in Right Calf | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Neck Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Spinal Stenosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Hand Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Plantar Fascitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Toe Surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Leg Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Knee Replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Groin Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Osteopenia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Jaw Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Sciatic Nerve Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Sore Coccyx | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Wrist Surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Nocturia | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Decreased Libido | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Kidney Stones | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Elevated PSA | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Testicular Pain | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Tip of Penis Swollen | Renal and urinary disorders | Non-systematic Assessment |
| ||
| BPH Symptoms | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Pain in Groin | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Incontinence | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Prostatitis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Small Spermatocele found in physical exam | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Prostate nodule left lobe | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Peyronies Disease | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Increase Firmness Erection | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Anal Itching | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Epididymitis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Increased PVR | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Trace WBC in Urine | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urological Disorder - Bloating | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hemorrhoids | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hernia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Reflux | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal Pains | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Rectal Bleed | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Barrett's Esophagus | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Fatty Liver | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Esophagitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| White Stool | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Upset Stomach/Flu | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Appendicitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Black Stool | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Colon Polyp | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Emesis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Irritable Bowel Syndrome | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Anal Itching | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alan Cantor | University of Alabama at Birmingham | (205) 934-6887 | acantor@uab.edu |
| ID | Term |
|---|---|
| D006965 | Hyperplasia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| >=65 years |
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| Male |
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| Canada |
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