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

Phase 2

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Dietary Supplement: Combination of 2007RD01 and saw palmetto lipidic extract; Dietary Supplement: Saw palmetto lipidic extract

• Registration Number: NCT00797394
• Lead Sponsor: innoVactiv Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-24
• Study First Submitted QC: 2008-11-24
• Study First Posted: 2008-11-25
• Primary Completion: 2010-07
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-11
• Last Update Posted: 2011-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treated	Combination of 2007RD01 and saw palmetto lipidic extract	-
Control	Saw palmetto lipidic extract	-

Primary Outcome Measures

Name	Time	Method
Absolute and relative (%) change in IPSS between baseline and end of study	90 days ±7 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Urology South Shore Research; 🇨🇦 Greenfield Park, Quebec, Canada

Recherches Cliniques Theradev; 🇨🇦 Granby, Quebec, Canada

Les Urologues Associés du CHUM; 🇨🇦 Montreal, Quebec, Canada

Clinique d'urologie Berger; 🇨🇦 Quebec, Canada