Status:
COMPLETED
CBD-based Therapy to Attenuate Non-bacterial Prostatitis Symptoms
Lead Sponsor:
Palacky University
Collaborating Sponsors:
CB21 Pharma Ltd.
Conditions:
Prostatitis
Eligibility:
MALE
18-50 years
Phase:
NA
Brief Summary
Efficacy and safety of the medical device rectal CANNEFF® SUP suppositories containing two active ingredients cannabidiol (CBD) and hyaluronic acid (HA) in alleviating non-bacterial prostatitis sympto...
Detailed Description
Chronic non-bacterial prostatitis/chronic pelvic pain syndrome (CP/CPPS) is the third most common urogenital diagnosis in men, following benign prostatic hyperplasia and prostate cancer, with an estim...
Eligibility Criteria
Inclusion
- men aged 18-50 years
- reported pelvic pain for ≥3 months in the past 6 months
- reported the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score \>10 with a pain subscore ≥4
- clinically and laboratory diagnosed CP/CPPS
Exclusion
- confirmed genitourinary infections (e.g., Escherichia coli, Enterococcus faecalis, Chlamydia spp.)
- recent antibiotic use (within 6 months)
- cannabis use
- alpha-blockers or phytotherapeutics in the preceding 4 weeks
- no history of pelvic trauma, surgery or radiotherapy, neurogenic bladder, post-void residual \>50 mL, or psychiatric disorders affecting compliance
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06968910
Start Date
December 1 2022
End Date
January 1 2025
Last Update
May 13 2025
Active Locations (1)
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1
Department of Urology, University Hospital Olomouc, Czech Republic
Olomouc, Czechia, 779 00