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

This study has been completed.
Sponsor:
Information provided by:
innoVactiv Inc.
ClinicalTrials.gov Identifier:
NCT00797394
First received: November 24, 2008
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Dietary Supplement: Combination of 2007RD01 and saw palmetto lipidic extract
Dietary Supplement: Saw palmetto lipidic extract
Phase 2

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

Resource links provided by NLM:


Further study details as provided by innoVactiv Inc.:

Primary Outcome Measures:
  • Absolute and relative (%) change in IPSS between baseline and end of study [ Time Frame: 90 days ±7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute and relative (%) change in IPSS between baseline and day 30 of follow-up [ Time Frame: 30 days ±7 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: November 2008
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797394

Locations
Canada, Quebec
Recherches Cliniques Theradev
Granby, Quebec, Canada, J2G 8Z9
Urology South Shore Research
Greenfield Park, Quebec, Canada, J4V 2H3
Les Urologues Associés du CHUM
Montreal, Quebec, Canada, H2X 1N8
Canada
Clinique d'urologie Berger
Quebec, Canada, G1S 2L6
Sponsors and Collaborators
innoVactiv Inc.
  More Information

No publications provided

Responsible Party: Jocelyn Bérubé / Scientific Director, Health & Nutrition, innoVactiv inc.
ClinicalTrials.gov Identifier: NCT00797394     History of Changes
Other Study ID Numbers: 2007-RD-01-CLN
Study First Received: November 24, 2008
Last Updated: April 11, 2011
Health Authority: Canada: Health Canada

Keywords provided by innoVactiv Inc.:
prostate
dietary supplements
saw palmetto
canada

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Permixon
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Androgen Antagonists

ClinicalTrials.gov processed this record on July 24, 2014