NCT00919893

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 1999

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
Same day until next milestone

Results Posted

Study results publicly available

June 12, 2009

Completed
Last Updated

November 20, 2020

Status Verified

June 1, 2009

Enrollment Period

4.1 years

First QC Date

February 10, 2009

Results QC Date

February 10, 2009

Last Update Submit

November 4, 2020

Conditions

Chronic ProstatitisChronic Pelvic Pain Syndrome

Keywords

chronic prostatitis symptom indexmaleinflammatoryCP-CPPSCerniltonpelvic painsymptoms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

    0, 6, 12 weeks

Study Arms (2)

Cernilton

ACTIVE COMPARATOR

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

Drug: Cernilton

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CerniltonDRUG

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.

Cernilton
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Justus-Liebig-University

Giessen, D-35392, Germany

Location

Related Publications (1)

  • 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.

    PMID: 8499988BACKGROUND

MeSH Terms

Conditions

Pelvic Pain

Interventions

cernilton

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. F.M.E. Wagenlehner
Organization
Clinic for urology and pediatric urology, JL-University, Giessen, Germany
wagenlehner@AOL.com
0049 641 9944518

Study Officials

  • Wolfgang Weidner, Prof. Dr.

    Clinic for Urology and Pediatric Urology, Justus-Liebig-University Giessen, Germany

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2009

First Posted

June 12, 2009

Study Start

December 1, 1999

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

November 20, 2020

Results First Posted

June 12, 2009

Record last verified: 2009-06

Locations

DE(1)