Phase 3 N=139 Randomized Double-blind Treatment

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

Chronic Prostatitis · Chronic Pelvic Pain Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00919893 ↗

Enrolled (actual)

139

Serious AEs

—

Results posted

Jun 2009

Primary outcome: Primary: Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) — 47; 33 participants — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Cernilton (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: University of Giessen
Primary completion: Jan 2004

Outcome Measures

Outcome	Result	p-value
PRIMARY Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)	47; 33	<0.05 sig
SECONDARY 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.	47; 33	—

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.

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT00919893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.