Title

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
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Intervention/Treatment

    cernilton ...
  • Study Participants

    139
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.
Study Started
Dec 31
1999
Primary Completion
Jan 31
2004
Study Completion
Jan 31
2004
Results Posted
Jun 12
2009
Estimate
Last Update
Nov 20
2020

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.

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.

Cernilton Active Comparator

Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)

Placebo Placebo Comparator

Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)

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

Summary

All Events

Event Type Organ System Event Term

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.

Cernilton

47.0
participants

Placebo

33.0
participants

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.

Cernilton

47.0
participants

Placebo

33.0
participants

Total

139
Participants

Age, Continuous

39.5
years (Mean)
Standard Deviation: 8.1

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Cernilton

Placebo

Drop/Withdrawal Reasons

Cernilton

Placebo