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CompletedNCT00797394Updated Apr 13, 2011

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

A Phase 2 interventional study of Combination of 2007RD01 and saw palmetto lipidic extract and Saw palmetto lipidic extract in Benign Prostatic Hyperplasia, sponsored by innoVactiv Inc.. Completed at 4 sites in Canada. Open to male participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-04-13.

Sponsored by innoVactiv Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Benign Prostatic Hyperplasia

Keywords

  • prostate
  • dietary supplements
  • saw palmetto
  • canada
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's planned enrollment of 110 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

innoVactiv Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Patient must be an adult man aged between 50 and 75
  • Patient must have Benign Prostatic Hyperplasia symptoms

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    Treated

    Dietary Supplement: Combination of 2007RD01 and saw palmetto lipidic extract

  • Active comparator
    Control

    Dietary Supplement: Saw palmetto lipidic extract

Interventions

  • Dietary supplementCombination 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 supplementSaw palmetto lipidic extract

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

06

What researchers measure

Primary outcomes

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

    Time frame: 90 days ±7 days

Secondary outcomes

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

    Time frame: 30 days ±7 days

  2. 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

  3. 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

  4. 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

  5. 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

07

Study locations

4 sites
  • Recherches Cliniques Theradev
    Granby, Quebec J2G 8Z9, Canada
  • Urology South Shore Research
    Greenfield Park, Quebec J4V 2H3, Canada
  • Les Urologues Associés du CHUM
    Montreal, Quebec H2X 1N8, Canada
  • Clinique d'urologie Berger
    Quebec, G1S 2L6, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00797394
Lead sponsor
innoVactiv Inc.
First posted
Nov 25, 2008
Start date
Nov 2008
Primary completion
Jul 2010
Last update
Apr 13, 2011
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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