Efficacy of Natural Extract 2007RD01 Combined With Saw Palmetto in Benign Prostatic Hyperplasia Patients Compared to Saw Palmetto
1 other identifier
interventional
110
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 24, 2008
CompletedFirst Posted
Study publicly available on registry
November 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedApril 13, 2011
April 1, 2011
1.7 years
November 24, 2008
April 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute and relative (%) change in IPSS between baseline and end of study
90 days ±7 days
Secondary Outcomes (5)
Absolute and relative (%) change in IPSS between baseline and day 30 of follow-up
30 days ±7 days
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
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
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
Change in sexual function between baseline and after 30 or 90 days of follow-up
30 days ±7 days , 90 days ±7 days
Study Arms (2)
Treated
EXPERIMENTALControl
ACTIVE COMPARATORInterventions
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
Oral administration of one capsule of 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals
Eligibility Criteria
You may qualify if:
- Patient must be an adult man aged between 50 and 75
- Patient must have Benign Prostatic Hyperplasia symptoms
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- innoVactiv Inc.lead
Study Sites (4)
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
Québec, Quebec, G1S 2L6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 24, 2008
First Posted
November 25, 2008
Study Start
November 1, 2008
Primary Completion
July 1, 2010
Last Updated
April 13, 2011
Record last verified: 2011-04