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

April 11, 2011 updated by: innoVactiv Inc.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1S 2L6
        • Clinique d'urologie Berger
    • Quebec
      • Granby, Quebec, Canada, J2G 8Z9
        • Recherches Cliniques Theradev
      • Greenfield Park, Quebec, Canada, J4V 2H3
        • Urology South Shore Research
      • Montreal, Quebec, Canada, H2X 1N8
        • Les Urologues Associes du CHUM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute and relative (%) change in IPSS between baseline and day 30 of follow-up
Time Frame: 30 days ±7 days
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
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
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
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
30 days ±7 days , 90 days ±7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

innoVactiv Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (Estimate)

November 25, 2008

Study Record Updates

Last Update Posted (Estimate)

April 13, 2011

Last Update Submitted That Met QC Criteria

April 11, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-RD-01-CLN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Benign Prostatic Hyperplasia

Clinical Trials on Combination of 2007RD01 and saw palmetto lipidic extract

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe