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

Primary Purpose

Benign Prostatic Hyperplasia

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Combination of 2007RD01 and saw palmetto lipidic extract

Saw palmetto lipidic extract

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring prostate, dietary supplements, saw palmetto, canada

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Recherches Cliniques Theradev
Urology South Shore Research
Les Urologues Associés du CHUM
Clinique d'urologie Berger

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treated

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Absolute and relative (%) change in post-void residual volume between baseline and after 30 or 90 days of follow-up

Change in health related quality of life between baseline and after 30 or 90 days of follow-up

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

Full Information

NCT ID

NCT00797394

First Posted

November 24, 2008

Last Updated

April 11, 2011

Sponsor

innoVactiv Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00797394

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

innoVactiv Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia

Keywords

prostate, dietary supplements, saw palmetto, canada

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treated

Arm Type

Experimental

Arm Title

Control

Arm Type

Active Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Combination of 2007RD01 and saw palmetto lipidic extract

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Saw palmetto lipidic extract

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

90 days ±7 days

Secondary Outcome Measure Information:

Title

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

Time Frame

30 days ±7 days

Title

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

Title

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

Title

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

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Recherches Cliniques Theradev

City

Granby

State/Province

Quebec

ZIP/Postal Code

J2G 8Z9

Country

Canada

Facility Name

Urology South Shore Research

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2H3

Country

Canada

Facility Name

Les Urologues Associés du CHUM

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 1N8

Country

Canada

Facility Name

Clinique d'urologie Berger

City

Quebec

ZIP/Postal Code

G1S 2L6

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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