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

innoVactiv Inc.110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

110

Conditions

Benign Prostatic Hyperplasia

Interventions

Combination of 2007RD01 and saw palmetto lipidic extractDIETARY_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

Saw palmetto lipidic extractDIETARY_SUPPLEMENT

Oral administration of one capsule of 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals

Eligibility

Sex: MALEMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (4)

Recherches Cliniques Theradev

Granby, Quebec, Canada

Urology South Shore Research

Greenfield Park, Quebec, Canada

Les Urologues Associés du CHUM

Montreal, Quebec, Canada

Clinique d'urologie Berger

Québec, Quebec, Canada

Outcomes

Primary Outcomes

Absolute and relative (%) change in IPSS between baseline and end of study

Time frame: 90 days ±7 days

Secondary Outcomes

Absolute and relative (%) change in IPSS between baseline and day 30 of follow-up

Time frame: 30 days ±7 days

Absolute and relative (%) change in peak urinary flow between baseline and after 30 or 90 days of follow-up

Time frame: 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

Time frame: 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

Time frame: 30 days ±7 days , 90 days ±7 days

Change in sexual function between baseline and after 30 or 90 days of follow-up

Time frame: 30 days ±7 days , 90 days ±7 days

Data from ClinicalTrials.gov

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