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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Prostatitis; Chronic Pelvic Pain Syndrome
• Intervention / Treatment: Drug: Cernilton; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 139
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Giessen, Germany, D-35392
    • Justus-Liebig-University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cernilton; Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)	Drug: Cernilton; 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.
Placebo Comparator: Placebo; Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)	Drug: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0, 6, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0, 6, 12 weeks

Collaborators and Investigators

• Sponsor: University of Giessen
• Collaborators: Strathmann AG&Co, Hamburg, Germany; Cernelle, Ängelholm, Sweden
• Investigators: Principal Investigator: Wolfgang Weidner, Prof. Dr., Clinic for Urology and Pediatric Urology, Justus-Liebig-University Giessen, Germany

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 1999
• Primary Completion (Actual): January 1, 2004
• Study Completion (Actual): January 1, 2004

Study Registration Dates

• First Submitted: February 10, 2009
• First Submitted That Met QC Criteria: April 27, 2009
• First Posted (Estimate): June 12, 2009

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: male; symptoms; inflammatory; pelvic pain; chronic prostatitis symptom index; CP-CPPS; Cernilton
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Disease; Prostatic Diseases; Syndrome; Chronic Disease; Somatoform Disorders; Pelvic Pain; Prostatitis
• Other Study ID Numbers: 4015497