Chronic ProstatitisPhase 3NCT00919893
Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)
A Phase 3 study testing Cernilton in people with Chronic Prostatitis and Chronic Pelvic Pain Syndrome, run by University of Giessen at 1 site in Germany.
Trial summary
In this placebo controlled study the safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory chronic prostatitis-chronic pelvic pain syndrome was investigated. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- What is being tested?
- Cernilton
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteGermany
- Study dates
- Dec 1999to Jan 2004
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men between 18 and 65 years
- symptoms of pelvic pain for at least 3 months during the 6 months before study entry
- a score in the pain domain of the German validated version of the NIH chronic prostatitis symptom index (NIH-CPSI) of 7 or higher
- leukocytes of 10 or more in post prostate massage urine
Who cannot join
- urinary tract infection
- acute bacterial or chronic bacterial prostatitis
- history of urethritis with discharge 4 weeks prior to study entry
- a history of epididymitis or sexually transmitted disease
- residual urine volume of more than 50 mL due to bladder outlet obstruction
- indication for or history of prostate surgery including prostate biopsy
Show all 9Show fewer
- treatment with phytotherapeutic agents
- alpha-blocker agents or antimicrobial substances with prostatic penetration 4 weeks prior to study entry
- treatment with agents influencing intraprostatic hormone metabolism 6 months prior to study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study of a Standardized Pollen Extract Preparation (Cernilton) in Patients With Inflammatory Chronic Prostatitis-chronic Pelvic Pain Syndrome
In this placebo controlled study the safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory chronic prostatitis-chronic pelvic pain syndrome was investigated. The purpose of this study is to determine whether Cernilton is safe and effective in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome.
Read the detailed description
We conducted a multicenter, randomized, double-blind, placebo-controlled trial to assess safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory CP-CPPS (National Institutes of Health (NIH) type IIIA). Participants were randomized to Cernilton or placebo for 12 weeks and were evaluated using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) individual domains and total score, the number of leukocytes in post prostatic massage urine, the International Prostate Symptom Score (IPSS) and the sexuality domain of a life satisfaction questionnaire at baseline and after 6 and 12 weeks.
- Conditions
- Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Being tested
- Cernilton, Placebo
- Keywords
- chronic prostatitis symptom index, male, inflammatory, CP-CPPS, Cernilton, pelvic pain, symptoms
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerniltonDrug
Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 23 mg Extractum Pollens siccatum, 4 mg L-glutamate and 0.23 mg Stigmasterol per capsule for 12 weeks.
PlaceboDrug
Oral placebo, 2 capsules every 8 hours with identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cernilton | Active comparator | Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS) Receives: Drug: Cernilton |
| Placebo | Placebo comparator | Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)
Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.
Measured: 0, 6, 12 weeks
Secondary outcomes (1)
Secondary Outcomes Were Symptomatic Improvement of the NIH-CPSI Total Score, the Micturition and Life Quality Domains of the NIH-CPSI Questionnaire, Decrease in the Number of Leukocytes in Urine.
Decrease of score points. Decrease of leucocytes in urine.
Measured: 0, 6, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startDec 1999
- Primary completionJan 2004
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic ProstatitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- Strathmann AG&Co, Hamburg, Germany, Cernelle, Ängelholm, Sweden
- Investigators
- Wolfgang Weidner, Prof. Dr., Principal investigator, Clinic for Urology and Pediatric Urology, Justus-Liebig-University Giessen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919893
- Sponsor's protocol ID
- 4015497
- Status last verified
- Jun 2009
- First submitted
- 10 Feb 2009
- Last updated
- 20 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rugendorff EW, Weidner W, Ebeling L, Buck AC. Results of treatment with pollen extract (Cernilton N) in chronic prostatitis and prostatodynia. Br J Urol. 1993 Apr;71(4):433-8. doi: 10.1111/j.1464-410x.1993.tb15988.x.
PubMed 8499988
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of a Standardized Pollen Extract Preparation (Cernilton) in Patients With Inflammatory Chronic Prostatitis-chronic Pelvic Pain Syndrome
- ClinicalTrials.gov ID
- NCT00919893
- Acronym / sponsor ID
- 4015497
- Conditions
- Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Keywords
- chronic prostatitis symptom index, male, inflammatory, CP-CPPS, Cernilton, pelvic pain, symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- Strathmann AG&Co, Hamburg, Germany, Cernelle, Ängelholm, Sweden
- Study start
- Dec 1999
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Posted 12 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this placebo controlled study the safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory chronic prostatitis-chronic pelvic pain syndrome was investigated. The purpose of this study is to determine whether Cernilton is safe and effective in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome.
Detailed description
We conducted a multicenter, randomized, double-blind, placebo-controlled trial to assess safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory CP-CPPS (National Institutes of Health (NIH) type IIIA). Participants were randomized to Cernilton or placebo for 12 weeks and were evaluated using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) individual domains and total score, the number of leukocytes in post prostatic massage urine, the International Prostate Symptom Score (IPSS) and the sexuality domain of a life satisfaction questionnaire at baseline and after 6 and 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cernilton | Active comparator | Drug: CerniltonMen with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS) |
| Placebo | Placebo comparator | Drug: PlaceboMen with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men between 18 and 65 years
- symptoms of pelvic pain for at least 3 months during the 6 months before study entry
- a score in the pain domain of the German validated version of the NIH chronic prostatitis symptom index (NIH-CPSI) of 7 or higher
- leukocytes of 10 or more in post prostate massage urine
Key exclusion criteria (9 listed)
- urinary tract infection
- acute bacterial or chronic bacterial prostatitis
- history of urethritis with discharge 4 weeks prior to study entry
- a history of epididymitis or sexually transmitted disease
- residual urine volume of more than 50 mL due to bladder outlet obstruction
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 |
|---|---|---|
| CerniltonOral Cernilton, 2 capsules every 8 hours with the active substance consisting of 23 mg Extractum Pollens siccatum, 4 mg L-glutamate and 0.23 mg Stigmasterol per capsule for 12 weeks. | Drug | Cernilton |
| PlaceboOral placebo, 2 capsules every 8 hours with identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks. | Drug | Placebo |
Primary outcome
Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)
Time frame: 0, 6, 12 weeks
Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.
1 secondary outcome
Secondary Outcomes Were Symptomatic Improvement of the NIH-CPSI Total Score, the Micturition and Life Quality Domains of the NIH-CPSI Questionnaire, Decrease in the Number of Leukocytes in Urine.
Time frame: 0, 6, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8499988Rugendorff EW, Weidner W, Ebeling L, Buck AC. Results of treatment with pollen extract (Cernilton N) in chronic prostatitis and prostatodynia. Br J Urol. 1993 Apr;71(4):433-8. doi: 10.1111/j.1464-410x.1993.tb15988.x.
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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.
Wolfgang Weidner, Prof. Dr. principal investigator
Clinic for Urology and Pediatric Urology, Justus-Liebig-University Giessen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cernilton in people with Chronic Prostatitis and Chronic Pelvic Pain Syndrome, run by University of Giessen at 1 site in Germany.
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 4 inclusion and 9 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 20 Nov 2020. 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 Germany. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) (time frame: 0, 6, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00919893, which also lists 1 linked publication.
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 20 Nov 2020.