A Phase 3 interventional study of Cernilton and Placebo in Chronic Prostatitis and Chronic Pelvic Pain Syndrome, sponsored by University of Giessen. Completed at 1 site in Germany. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-11-20.
Sponsored by University of Giessen · Phase 3, Interventional, and Treatment
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.
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.
376 studies on the registry are indexed under Pelvic Pain; 90 are open to participants now.
This study's enrollment of 139 is above the median of 60 across 278 interventional studies indexed under Pelvic Pain.
Browse Pelvic Pain studies →University of Giessen is the lead sponsor of 95 studies on the registry; 22 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
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Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)
Drug: Cernilton
Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)
Drug: Placebo
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.
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.
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.
Time frame: 0, 6, 12 weeks
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.
Time frame: 0, 6, 12 weeks
Outpatients at urologic clinics. Start date: December 1999. Stop date: January 2004.
| Milestone | Cernilton | Placebo |
|---|---|---|
| Started | 70 | 69 |
| Completed | 51 | 60 |
| Not completed | 19 | 9 |
| Withdrew: Protocol violation | 19 | 9 |
Decrease of score points. Decrease of leucocytes in urine.
| participants | Cernilton | Placebo |
|---|---|---|
| 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. | 47 | 33 |
Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.
| participants | Cernilton | Placebo |
|---|---|---|
| Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | 47 | 33 |
| Age, Categorical(Participants) | Cernilton | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 70 | 69 | 139 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Cernilton | Placebo | Total |
|---|---|---|---|
| Mean | 39.7 ± 7.2 | 39.3 ± 9.1 | 39.5 ± 8.1 |
| Sex: Female, Male(Participants) | Cernilton | Placebo | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 70 | 69 | 139 |
| Region of Enrollment(participants) | Cernilton | Placebo | Total |
|---|---|---|---|
| Germany | 70 | 69 | 139 |
The record gives a start of Dec 1999, a primary completion of Jan 2004 and a completion of Jan 2004. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2009, 5 years 5 months after primary completion.
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University of Giessen