The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome
This study tests whether OM-89, a medication derived from bacteria, can safely and effectively reduce symptoms in men with chronic prostatitis and chronic pelvic pain syndrome who experience recurring episodes. Participants will be evaluated to see if OM-89 helps decrease pain and other symptoms associated with this condition.
Key Objective: The trial is testing whether OM-89 can provide safe and effective relief from recurring prostate-related pain and symptoms in men with chronic prostatitis.
Who to Consider: Men with recurrent chronic prostatitis and chronic pelvic pain syndrome who have not found adequate relief with other treatments should consider enrolling.
Trial Parameters
Brief Summary
This study is planned to Evaluate the Efficacy and Safety of OM-89 in Patients with Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Eligibility Criteria
Inclusion Criteria: * Male adults aged ≥19 to ≤55 at the time of obtaining the written consent * Those who have t pain or discomfort in the pelvic or genital area * NIH-CPSI (the National Institutes of Health Chronic Prostatitis Symptom Index) ≥ 15 in total score * voluntarily signed the informed consent form to participate in this study Exclusion Criteria: * Prostate specific antigen (PSA) ≥ 4.0 ng/ml at Visit 1 (screening) * Received a prostate biopsy, surgery, or treatment within 12 weeks before Visit 1 (screening) * Past or current medical history as Herpes infection treatment within 1 year before the Screening,Treatment for genital infections or sexually transmitted diseases and History of urogenital tumors. * Those who have a medication history of the drugs(Drugs or health functional food, Health functional foods that affect prostate function etc)or have a plan to receive them during the study at Visit 1