ProstatitisUrol-CBDNCT06968910
CBD-based Therapy to Attenuate Non-bacterial Prostatitis Symptoms
A study testing CANNEFF® SUP rectal suppositories in people with Prostatitis, run by Palacky University at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Prostatitis
- What is being tested?
- CANNEFF® SUP rectal suppositories
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Dec 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Urology, University Hospital Olomouc, Czech Republic
Olomouc, 779 00
About this study
Official title: Cannabidiol-based Therapy to Attenuate Non-bacterial Prostatitis Symptoms - Single-arm Open-label Pilot Clinical Trial With Intrarectal Administration
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.
Read the 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
- Being tested
- CANNEFF® SUP rectal suppositories
- Keywords
- prostatitis, chronic pelvic pain, cannabidiol and hyaluronic acid, rectal delivery
- Medical subject headings
- Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CANNEFF® SUP rectal suppositoriesDevice
CANNEFF® SUP suppositories with cannabidiol (CBD = 100 mg) and hyaluronic acid (HA = 6.6 mg) as active ingredients
| Study group | Role | What they receive |
|---|---|---|
| CBD-based therapy | Experimental | Participants self-administered nightly intrarectal cannabidiol (CBD)-based suppositories for 30 consecutive days. Receives: Device: CANNEFF® SUP rectal suppositories |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 30 days
Safety Profile Evaluation
Adverse events reported were monitored after 30 d of intervention.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Dec 2022
- Primary completion1 Apr 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ProstatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palacky University
- Sponsor type
- University, hospital or other
- Collaborators
- CB21 Pharma Ltd.
- Responsible party
- Principal investigator, Jan Vacek, Palacky University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968910
- Sponsor's protocol ID
- 176/22
- Acronym
- Urol-CBD
- Status last verified
- May 2025
- First submitted
- 26 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9187685Barry 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.
PubMed 1279218Litwin 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.
PubMed 10411041Nickel 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.
PubMed 11176483
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol-based Therapy to Attenuate Non-bacterial Prostatitis Symptoms - Single-arm Open-label Pilot Clinical Trial With Intrarectal Administration
- ClinicalTrials.gov ID
- NCT06968910
- Acronym / sponsor ID
- Urol-CBD / 176/22
- Conditions
- Prostatitis
- Keywords
- prostatitis, chronic pelvic pain, cannabidiol and hyaluronic acid, rectal delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Palacky UniversityUniversity, hospital or other
- Collaborators
- CB21 Pharma Ltd.
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBD-based therapy | Experimental | Device: CANNEFF® SUP rectal suppositoriesParticipants self-administered nightly intrarectal cannabidiol (CBD)-based suppositories for 30 consecutive days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CANNEFF® SUP rectal suppositoriesCANNEFF® SUP suppositories with cannabidiol (CBD = 100 mg) and hyaluronic acid (HA = 6.6 mg) as active ingredients | Device | CBD-based therapy |
Primary outcome
Alleviating Chronic Non-bacterial Prostatitis Symptoms
Time frame: 30 days
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.
Alleviating Chronic Pelvic Pain Symptoms
Time frame: 30 days
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.
3 secondary outcomes
International Prostate Symptom Score Evaluation
Time frame: 30 days
Erectile Function Evaluation
Time frame: 30 days
Safety Profile Evaluation
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 9187685Rosen 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.
- Background: PubMed 1279218Barry 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.
- Background: PubMed 10411041Litwin 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.
- Background: PubMed 11176483Nickel 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.
- Individual participant dataSharing planned: No
Related trials for Prostatitis
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Enrolling by invitation
Pulsed Electromagnetic Versus Hydrotherapy on Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome
Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
Not yet recruitingPhase 3
FOsfomycin for Male Urinary Tract Infection
Urinary Tract Infection, Prostatitis
RecruitingObservational study
Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Prostatitis (CP), Chronic Pelvic Pain Syndrome (CPPS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CANNEFF® SUP rectal suppositories in people with Prostatitis, run by Palacky University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alleviating Chronic Non-bacterial Prostatitis Symptoms (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06968910, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.