Efficacy of Natural Extract 2007RD01 Combined With Saw Palmetto in Benign Prostatic Hyperplasia Patients Compared to Saw Palmetto

Study Overview
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Brief Summary
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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.

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Dietary Supplement: Combination of 2007RD01 and saw palmetto lipidic extract
* Dietary Supplement: Saw palmetto lipidic extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be an adult man aged between 50 and 75 Patient must have Benign Prostatic Hyperplasia symptoms Exclusion Criteria: Patient has a malfunction of the urinary tract, is suffering from acute urinary retention, or is suffering from prostate cancer or urinary tract infection Patient has been subjected to surgery of the prostate, bladder or urethra Patient has taken a 5-alpha-reductase inhibitor in the 6-month period preceding screening Patient has taken an alpha-blocker in the 2-week period preceding screening

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated<br> | Dietary Supplement: Combination of 2007RD01 and saw palmetto lipidic extract<br>* 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<br>|
| Active Comparator: Control<br> | Dietary Supplement: Saw palmetto lipidic extract<br>* Oral administration of one capsule of 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute and relative (%) change in IPSS between baseline and end of study |  | 90 days ±7 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate, dietary supplements, saw palmetto, canada