An interventional study of CANNEFF® SUP rectal suppositories in Prostatitis, sponsored by Palacky University. Completed at 1 site in Czech Republic. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by Palacky University · Not applicable, Interventional, and Supportive care
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 symptoms and improving quality of life in men will be evaluated.
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 estimated prevalence reaching 8.2%. Clinically, CP/CPPS often presents with persistent pelvic pain, lower urinary tract symptoms (LUTS), and sexual dysfunction, all of which can substantially diminish quality of life. Psychological comorbidities, including anxiety, stress, and depression, further amplify the burden on patients. Despite its considerable socioeconomic impact, no definitive treatment consensus exists for CP/CPPS. This study assessed the effects of rectal administration of cannabidiol (CBD)-based therapy in men with CP/CPPS. A single-arm, open-label pilot trial on men with CP/CPPS (NIH Chronic Prostatitis Symptom Index [NIH-CPSI] >10, pain subscore ≥4). The participants self-administered rectal CANNEFF® suppositories containing CBD (100 mg) and hyaluronic acid (HA = 6.6 mg) as active ingredients, nightly for 30 days. Outcome measures included changes in NIH-CPSI total score, International Prostate Symptom Score (IPSS), and International Index of Erectile Function (IIEF-5). Safety and tolerability were assessed.
88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.
This study's enrollment of 35 is below the median of 60 across 73 interventional studies indexed under Prostatitis.
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Participants self-administered nightly intrarectal cannabidiol (CBD)-based suppositories for 30 consecutive days.
Device: CANNEFF® SUP rectal suppositories
CANNEFF® SUP suppositories with cannabidiol (CBD = 100 mg) and hyaluronic acid (HA = 6.6 mg) as active ingredients
Alleviating Chronic Non-bacterial Prostatitis Symptoms
The primary outcome was the change in NIH Chronic Prostatitis Symptom Index (NIH-CPSI) total score between baseline (Day 0) and Day 30. The NIH-CPSI has a total score range from 0 to 43, and it includes three subscales addressing pain (score range 0-21), urinary symptoms (score range 0-10), and quality of life (QOL) (score range 0-12). Higher score means a worse outcome.
Time frame: 30 days
Alleviating Chronic Pelvic Pain Symptoms
The changes in the NIH-CPSI pain subscore (score range 0-21) were evaluated to capture the specific impact on pelvic pain. Higher score means a worse outcome.
Time frame: 30 days
International Prostate Symptom Score Evaluation
Secondary outcome measures included the International Prostate Symptom Score (IPSS). The IPSS evaluates lower urinary tract symptoms (both storage and voiding). A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. The index was assessed at baseline and again on Day 30.
Time frame: 30 days
Erectile Function Evaluation
The five-item International Index of Erectile Function (IIEF-5) was evaluated, whereas the IIEF-5 provides a brief assessment of erectile function (higher scores indicating better function). Interpretation: score 22-25 - No erectile dysfunction, 17-21 - Mild erectile dysfunction, 12-16 - Mild to moderate erectile dysfunction, 8-11 - Moderate erectile, 5-7 - Severe erectile dysfunction. The index was assessed at baseline and again on Day 30.
Time frame: 30 days
Safety Profile Evaluation
Adverse events reported were monitored after 30 d of intervention.
Time frame: 30 days
Plan to share: No
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Palacky University