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

Benign Prostatic Hyperplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797394
• Other study ID #: 2007-RD-01-CLN
• Status: Completed
• Phase: Phase 2
• First received: November 24, 2008
• Last updated: April 11, 2011
• Start date: November 2008

Study information

• Verified date: April 2011
• Source: innoVactiv Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	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	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
innoVactiv Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute and relative (%) change in IPSS between baseline and end of study		90 days ±7 days	No
Secondary	Absolute and relative (%) change in IPSS between baseline and day 30 of follow-up		30 days ±7 days	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change in sexual function between baseline and after 30 or 90 days of follow-up		30 days ±7 days , 90 days ±7 days	Yes