The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pa… (NCT06345014) | Clinical Trial Compass
UnknownPhase 4
The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome
South Korea332 participantsStarted 2023-12-20
Plain-language 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)
Who can participate
Age range19 Years – 55 Years
SexMALE
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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