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

November 24, 2008
April 11, 2011
November 2008
July 2010   (final data collection date for primary outcome measure)
Absolute and relative (%) change in IPSS between baseline and end of study [ Time Frame: 90 days ±7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00797394 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy of Natural Extract 2007RD01 Combined With Saw Palmetto in Benign Prostatic Hyperplasia Patients Compared to Saw Palmetto
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Benign Prostatic Hyperplasia
  • 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
  • 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
    Intervention: Dietary Supplement: Combination of 2007RD01 and saw palmetto lipidic extract
  • Active Comparator: Control
    Intervention: Dietary Supplement: Saw palmetto lipidic extract
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
Not Provided
July 2010   (final data collection date for primary outcome measure)

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
Male
50 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00797394
2007-RD-01-CLN
Not Provided
Jocelyn Bérubé / Scientific Director, Health & Nutrition, innoVactiv inc.
innoVactiv Inc.
Not Provided
Not Provided
innoVactiv Inc.
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP