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The purpose of this study is to determine if the combination of 2007RD01, a natural extract, and saw palmetto lipidic extract, is more effective at treating lower urinary tract symptoms associated with benign prostatic hyperplasia than saw palmetto lipidic extract alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated | Experimental |
| |
| Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of 2007RD01 and saw palmetto lipidic extract | Dietary Supplement | Oral administration of one capsule containing a combination of 250 mg of 2007RD01 (a natural extract) and 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute and relative (%) change in IPSS between baseline and end of study | 90 days ±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute and relative (%) change in IPSS between baseline and day 30 of follow-up | 30 days ±7 days | |
| Absolute and relative (%) change in peak urinary flow between baseline and after 30 or 90 days of follow-up | 30 days ±7 days , 90 days ±7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recherches Cliniques Theradev | Granby | Quebec | J2G 8Z9 | Canada | ||
| Urology South Shore Research |
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| Saw palmetto lipidic extract | Dietary Supplement | Oral administration of one capsule of 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals |
|
| Absolute and relative (%) change in post-void residual volume between baseline and after 30 or 90 days of follow-up | 30 days ±7 days , 90 days ±7 days |
| Change in health related quality of life between baseline and after 30 or 90 days of follow-up | 30 days ±7 days , 90 days ±7 days |
| Change in sexual function between baseline and after 30 or 90 days of follow-up | 30 days ±7 days , 90 days ±7 days |
| Greenfield Park |
| Quebec |
| J4V 2H3 |
| Canada |
| Les Urologues Associés du CHUM | Montreal | Quebec | H2X 1N8 | Canada |
| Clinique d'urologie Berger | Québec | Quebec | G1S 2L6 | Canada |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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