Status:
COMPLETED
Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)
Lead Sponsor:
University of Giessen
Collaborating Sponsors:
Strathmann AG&Co, Hamburg, Germany
Cernelle, Ängelholm, Sweden
Conditions:
Chronic Prostatitis
Chronic Pelvic Pain Syndrome
Eligibility:
MALE
18-65 years
Phase:
PHASE3
Brief 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. The pu...
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 Ins...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT00919893
Start Date
December 1 1999
End Date
January 1 2004
Last Update
November 20 2020
Active Locations (1)
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1
Justus-Liebig-University
Giessen, Germany, D-35392