An interventional study of Prospidol suppository in Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), sponsored by S&R Farmaceutici S.p.A.. Completed at 2 sites in Italy. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by S&R Farmaceutici S.p.A. · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to evaluate whether a medical device is effective and safe in treating chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in adult men.
The main questions it aims to answer are:
Participants will:
Use one suppository daily for 10 days each month for 3 months Attend clinical visits at the start of the study and after 30, 60, and 90 days Complete validated questionnaires (NIH-CPSI, IPSS, SF-36, IIEF) at each visit Report any side effects or symptoms throughout the study At the end of the study, researchers will analyze symptom improvement, quality of life changes, and treatment tolerability.
88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 73 interventional studies indexed under Prostatitis.
Browse Prostatitis studies →S&R Farmaceutici S.p.A. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients enrolled in this arm will take 1 Prospidol suppository per day, to be administered before going to bed for 10 days each month, for a total period of 3 months
Device: Prospidol suppository
Prospidol is a medical device containing sodium hyaluronate, Boswellia serrata extract (65% boswellic acid), mallow extract, rice bran oil and Eugenia caryophyllus essential oil. The recommended dosage is: 1 suppository per day, to be taken before bedtime, for 10 days a month, for 3 months.
Change of National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) score
The primary outcome of the study is the assessment of the change in the National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI score, ranging from 0 to 43, where an improvement in symptoms is characterised by a decrease in the score) after one month of treatment. Specifically, a change in pain symptoms of more than 30% compared with T0 is expected, given that the literature reports that patients with comparable characteristics, when treated with placebo, may experience a pain reduction of up to 30%.
Time frame: From enrollment to the end of treatment at 4 weeks
Comparison of the National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) scores
Comparison of the National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI, ranging from 0 to 43, where an improvement in symptoms is characterised by a decrease in the score) scores between baseline and follow-ups
Time frame: 0, 1, 2, 3 months after enrollment
Comparison of the International Prostate Symptom Score (IPSS)
Comparison of the International Prostate Symptom Score (IPSS, ranging from 0 and 35, where an improvement in symptoms corresponds to a decrease in the score) between baseline and follow-ups
Time frame: 0, 1, 2, 3 months after enrollment
Comparison of the Short Form 36 (SF-36) score
Comparison of the Short Form 36 (SF-36, ranging from 0 to 100, where an improvement in symptoms corresponds to a decrease in the score) score between baseline and follow-ups
Time frame: 0, 1, 2, 3 months after enrollment
Comparison of the International Index of Erectile Funtion (IIEF)
Comparison of the International Index of Erectile Funtion score(IIEF, ranging from 5 to 25, where an improvement in symptoms corresponds to a higher score) between baseline and follow-ups
Time frame: 0, 1, 2, 3 months after enrollment
Plan to share: No
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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S&R Farmaceutici S.p.A.