Sexual Dysfunctions in Men With Benign Prostatic HyperplasiaPhase 4NCT01021267
Clinical Study to Assess the Influence of a Saw Palmetto Preparation in Patients With Benign Prostatic Hyperplasia (BPH) and Sexual Dysfunctions
A Phase 4 study testing Saw palmetto berry extract in people with Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia, run by A. Vogel AG at 1 site in Switzerland.
Trial summary
Assessment in an open trial if a standardized saw palmetto preparation has a positive influence on sexual dysfunctions in patients with BPH and sexual dysfunctions. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia
- What is being tested?
- Saw palmetto berry extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2009to Sep 2010
- Phase
- Phase 4
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with BPH and sexual dysfunctions (erectile dysfunction or decrease in libido)
- IPSS > 4
- BSFI, sexual drive questions < 5
Who cannot join
- Lack of libido which is due to a psychic disease or a depressive mood -Excessivly strong lack of libido in the judgement of the investigator within the last two months
- Patients with severe vascular disorders (microangiopathies)
- Patients with known neuropathies
- Severe diabetes mellitus
- Patients with hypertension who are for less than two months on a stable antihypertensive medication
- Known bad compliance of the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Pilot Trial on the Influence of a Saw Palmetto Berry Preparation on Sexual Functions in Patients With Benign Prostatic Hyperplasia
Assessment in an open trial if a standardized saw palmetto preparation has a positive influence on sexual dysfunctions in patients with BPH and sexual dysfunctions.
- Being tested
- Saw palmetto berry extract
- Keywords
- sexual dysfunctions, benign prostatic hyperplasia, saw palmetto
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saw palmetto berry extractDrug
Also called Prostasan
1x daily 1 capsule containing 320mg lipophilic extract
| Study group | Role | What they receive |
|---|---|---|
| Saw palmetto berry extract | Experimental | Saw palmetto berry extract, organic saw palmetto, ethanolic extract 96% Receives: Drug: Saw palmetto berry extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the brief Sexual Function Inventory
Measured: day 0 and day 56
Secondary outcomes (1)
change in IPSS change in Urolife Quality of Life questionnaire
Measured: day 0 and day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Dysfunctions in Men With 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A. Vogel AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of London
- Investigators
- Eugen Riedi, MD, Principal investigator, independent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021267
- Sponsor's protocol ID
- 920136
- Status last verified
- Nov 2009
- First submitted
- 25 Nov 2009
- Last updated
- 26 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pilot Trial on the Influence of a Saw Palmetto Berry Preparation on Sexual Functions in Patients With Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT01021267
- Acronym / sponsor ID
- 920136
- Keywords
- sexual dysfunctions, benign prostatic hyperplasia, saw palmetto
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- A. Vogel AGIndustry (pharma, biotech, devices)
- Collaborators
- University of London
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 26 Nov 2009 (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.
Assessment in an open trial if a standardized saw palmetto preparation has a positive influence on sexual dysfunctions in patients with BPH and sexual dysfunctions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saw palmetto berry extract | Experimental | Drug: Saw palmetto berry extractSaw palmetto berry extract, organic saw palmetto, ethanolic extract 96% |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with BPH and sexual dysfunctions (erectile dysfunction or decrease in libido)
- IPSS > 4
- BSFI, sexual drive questions < 5
Key exclusion criteria (6 listed)
- Lack of libido which is due to a psychic disease or a depressive mood -Excessivly strong lack of libido in the judgement of the investigator within the last two months
- Patients with severe vascular disorders (microangiopathies)
- Patients with known neuropathies
- Severe diabetes mellitus
- Patients with hypertension who are for less than two months on a stable antihypertensive medication
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 |
|---|---|---|
| Saw palmetto berry extractAlso: Prostasan1x daily 1 capsule containing 320mg lipophilic extract | Drug | Saw palmetto berry extract |
Primary outcome
Change of the brief Sexual Function Inventory
Time frame: day 0 and day 56
1 secondary outcome
change in IPSS change in Urolife Quality of Life questionnaire
Time frame: day 0 and day 56
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2009.
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.
Eugen Riedi, MD principal investigator
independent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saw palmetto berry extract in people with Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia, run by A. Vogel AG at 1 site in Switzerland.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andy Suter, M.Sc. (0041714546203, a.suter@bioforce.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the brief Sexual Function Inventory (time frame: day 0 and day 56). 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 26 Nov 2009.