Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: Male

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 purpose of this study is to determine whether Cernilton is safe and effective in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Giessen
• Collaborators: Cernelle, Ängelholm, Sweden; Strathmann AG&Co, Hamburg, Germany

Criteria

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