Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)
CompletedPhase 3NCT00919893
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Phase 3 Study of a Standardized Pollen Extract Preparation (Cernilton) in Patients With Inflammatory Chronic Prostatitis-chronic Pelvic Pain Syndrome
- Interventions
- Drug: Cernilton
- Drug: Placebo
- Sponsor
- University of Giessen
- Collaborators
- Strathmann AG&Co, Hamburg, Germany; Cernelle, Ängelholm, Sweden
- Start date
- 1999-12
- Primary completion
- 2004-01
- Sex
- Male
- Age range
- from 18 Years to 65 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Germany
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00919893