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OpenTrials
Completed

NCT Number: NCT00797394

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Recherches Cliniques Theradev, Granby, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combination of 2007RD01 and saw palmetto lipidic extract

Dietary Supplement

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

Dietary Supplement

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

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

Sponsors and collaborators

Lead sponsor

innoVactiv Inc.

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
First posted
Nov 25, 2008
Registry last updated
Apr 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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