Benign Prostatic HyperplasiaPhase 2NCT00797394
Efficacy of Natural Extract 2007RD01 Combined With Saw Palmetto in Benign Prostatic Hyperplasia Patients Compared to Saw Palmetto
A Phase 2 study testing Combination of 2007RD01 and saw palmetto lipidic extract and Saw palmetto lipidic extract in people with Benign Prostatic Hyperplasia, run by innoVactiv Inc. at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Combination of 2007RD01 and saw palmetto lipidic extract and Saw palmetto lipidic extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesCanada
- Study dates
- Nov 2008to Jul 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be an adult man aged between 50 and 75
- Patient must have Benign Prostatic Hyperplasia symptoms
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Recherches Cliniques Theradev
Granby, Quebec, J2G 8Z9
Urology South Shore Research
Greenfield Park, Quebec, J4V 2H3
Les Urologues Associés du CHUM
Montreal, Quebec, H2X 1N8
Clinique d'urologie Berger
Québec, Quebec, G1S 2L6
About this study
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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Combination of 2007RD01 and saw palmetto lipidic extract, Saw palmetto lipidic extract
- Keywords
- prostate, dietary supplements, saw palmetto, canada
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of 2007RD01 and saw palmetto lipidic extractDietary 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 extractDietary supplement
Oral administration of one capsule of 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals
| Study group | Role | What they receive |
|---|---|---|
| Treated | Experimental | Not described Receives: Dietary Supplement: Combination of 2007RD01 and saw palmetto lipidic extract |
| Control | Active comparator | Not described Receives: Dietary Supplement: Saw palmetto lipidic extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute and relative (%) change in IPSS between baseline and end of study
Measured: 90 days ±7 days
Secondary outcomes (5)
Absolute and relative (%) change in IPSS between baseline and day 30 of follow-up
Measured: 30 days ±7 days
Absolute and relative (%) change in peak urinary flow between baseline and after 30 or 90 days of follow-up
Measured: 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
Measured: 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
Measured: 30 days ±7 days , 90 days ±7 days
Change in sexual function between baseline and after 30 or 90 days of follow-up
Measured: 30 days ±7 days , 90 days ±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- innoVactiv Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797394
- Sponsor's protocol ID
- 2007-RD-01-CLN
- Status last verified
- Apr 2011
- First submitted
- 24 Nov 2008
- Last updated
- 13 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Natural Extract 2007RD01 Combined With Saw Palmetto in Benign Prostatic Hyperplasia Patients Compared to Saw Palmetto
- ClinicalTrials.gov ID
- NCT00797394
- Acronym / sponsor ID
- 2007-RD-01-CLN
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- prostate, dietary supplements, saw palmetto, canada
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- innoVactiv Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jul 2010 (actual)
- First posted
- 25 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated | Experimental | Dietary Supplement: Combination of 2007RD01 and saw palmetto lipidic extract |
| Control | Active comparator | Dietary Supplement: Saw palmetto lipidic extract |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient must be an adult man aged between 50 and 75
- Patient must have Benign Prostatic Hyperplasia symptoms
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of 2007RD01 and saw palmetto lipidic extractOral 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 | Treated |
| Saw palmetto lipidic extractOral administration of one capsule of 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals | Dietary supplement | Control |
Primary outcome
Absolute and relative (%) change in IPSS between baseline and end of study
Time frame: 90 days ±7 days
5 secondary outcomes
Absolute and relative (%) change in IPSS between baseline and day 30 of follow-up
Time frame: 30 days ±7 days
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combination of 2007RD01 and saw palmetto lipidic extract and Saw palmetto lipidic extract in people with Benign Prostatic Hyperplasia, run by innoVactiv Inc. at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute and relative (%) change in IPSS between baseline and end of study (time frame: 90 days ±7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2011.