NCT06968910

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

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, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

1.3 years

First QC Date

April 26, 2025

Last Update Submit

May 5, 2025

Conditions

Prostatitis

Keywords

prostatitischronic pelvic paincannabidiol and hyaluronic acidrectal delivery

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    30 days

Secondary Outcomes (3)

  • International Prostate Symptom Score Evaluation

    30 days

  • Erectile Function Evaluation

    30 days

  • Safety Profile Evaluation

    30 days

Study Arms (1)

CBD-based therapy

EXPERIMENTAL

Participants self-administered nightly intrarectal cannabidiol (CBD)-based suppositories for 30 consecutive days.

Device: CANNEFF® SUP rectal suppositories

Interventions

CANNEFF® SUP rectal suppositoriesDEVICE

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

CBD-based therapy

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly biological male identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, University Hospital Olomouc, Czech Republic

Olomouc, 779 00, Czechia

Location

Related Publications (4)

  • Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.

    PMID: 9187685BACKGROUND

  • Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.

    PMID: 1279218BACKGROUND

  • Litwin MS, McNaughton-Collins M, Fowler FJ Jr, Nickel JC, Calhoun EA, Pontari MA, Alexander RB, Farrar JT, O'Leary MP. The National Institutes of Health chronic prostatitis symptom index: development and validation of a new outcome measure. Chronic Prostatitis Collaborative Research Network. J Urol. 1999 Aug;162(2):369-75. doi: 10.1016/s0022-5347(05)68562-x.

    PMID: 10411041BACKGROUND

  • Nickel JC, Downey J, Hunter D, Clark J. Prevalence of prostatitis-like symptoms in a population based study using the National Institutes of Health chronic prostatitis symptom index. J Urol. 2001 Mar;165(3):842-5.

    PMID: 11176483BACKGROUND

MeSH Terms

Conditions

Prostatitis

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Olomouc University Hospital

Study Record Dates

First Submitted

April 26, 2025

First Posted

May 13, 2025

Study Start

December 1, 2022

Primary Completion

April 1, 2024

Study Completion

January 1, 2025

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)