[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"S&R Farmaceutici S.p.A.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100646902","clinical-evaluation-of-the-efficacy-and-safety-of-a-medical-device-in-the-form-of-rectal-suppositories-prospidol-for-the-treatment-of-symptoms-associated-with-chronic-prostatitischronic-pelvic-pain-syndrome-100646902",false,"NCT07685847","Clinical Evaluation of the Efficacy and Safety of a Medical Device in the Form of Rectal Suppositories (Prospidol®) for the Treatment of Symptoms Associated With Chronic Prostatitis\u002FChronic Pelvic Pain Syndrome.","Inclusion Criteria:\n\n* male subjects aged between 18 and 60;\n* clinical presentation typical of prostatitis and a clinical diagnosis of chronic prostatitis type IIIa or IIIb (CP\u002FCPPS) for at least 3 months;\n* no treatment for at least 2 months;\n* PSA \\\u003C 3 ng\u002FmL;\n* digital rectal examination negative for nodules or BPH;\n* negative microbiological tests on urine and seminal fluid;\n* baseline score on the validated Italian version of the NIH-CPSI pain domain questionnaire \\> 7 or total NIH-CPSI score \\> 15;\n* digital rectal examination not suggestive of prostate cancer.\n\nExclusion Criteria:\n\n* patients with signs of infection and a PSA level \\> 3 ng\u002Fml;\n* other active prostate conditions;\n* patients with active neoplastic, neurodegenerative or immunological conditions, those who are immunocompromised, or those who are already taking supplements or functional foods for any reason;\n* patients undergoing treatment with systemic or topical corticosteroids;\n* patients who will not sign the informed consent form;\n* patients unable to participate in a clinical trial for any reason (e.g. psychiatric patients, those with cancer, on dialysis, or with severe liver or kidney failure);\n* patients with allergies to any of the components of the medical device (MD) under investigation.","MALE","18 Years","60 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to evaluate whether a medical device is effective and safe in treating chronic prostatitis\u002Fchronic pelvic pain syndrome (CP\u002FCPPS) in adult men.\n\nThe main questions it aims to answer are:\n\n* Does the treatment reduce pain symptoms (measured by NIH-CPSI score) by more than 30% after one month?\n* Does the treatment improve urinary symptoms, quality of life, and sexual function?\n* What adverse events or side effects occur during treatment? Researchers will conduct a multicenter, open-label study involving 40 participants diagnosed with CP\u002FCPPS. All participants will receive the same treatment, and their outcomes will be monitored over time.\n\nParticipants will:\n\nUse 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.",[26],"Chronic Prostatitis\u002FChronic Pelvic Pain Syndrome (CP\u002FCPPS)",[28,29,30,31],"prostate","prostatitis","suppository","CP\u002FCPPS","RECRUITING","2026-06-29",{"date":35,"type":36},"2026-07-06","ACTUAL",{"date":38,"type":36},"2025-09-01",{"date":40,"type":20},"2026-09",{"name":42,"class":43},"S&R Farmaceutici S.p.A.","INDUSTRY",2,""]