CompletedPhase 3

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

Germany139 participantsStarted 1999-12

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)

Timeframe: 0, 6, 12 weeks

Trial details

NCT IDNCT00919893

SponsorUniversity of Giessen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2004-01

Results submitted2009-02-10

View on ClinicalTrials.gov More Chronic Prostatitis trials