NCT06968910

CBD-based Therapy to Attenuate Non-bacterial Prostatitis Symptoms

Cannabidiol-based Therapy to Attenuate Non-bacterial Prostatitis Symptoms - Single-arm Open-label Pilot Clinical Trial With Intrarectal Administration

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Palacky University · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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 symptoms and improving quality of life in men will be evaluated.

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 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.

Conditions

• Prostatitis

Interventions

Type	Name	Description
DEVICE	CANNEFF® SUP rectal suppositories	CANNEFF® SUP suppositories with cannabidiol (CBD = 100 mg) and hyaluronic acid (HA = 6.6 mg) as active ingredients

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-04-01
• Completion: 2025-01-01
• First posted: 2025-05-13
• Last updated: 2025-05-13

Locations

1 site across 1 country: Czechia