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

University of Giessen

Status and phase

Completed

Phase 3

Conditions

Chronic Prostatitis

Chronic Pelvic Pain Syndrome

Treatments

Drug: Cernilton

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00919893

4015497

Details and patient eligibility

About

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.

Full 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.

Enrollment

139 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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