The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome
A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase 4 Study to Evaluate the Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
AJU Pharm Co., Ltd.
332 participants
Dec 20, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria4
- 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
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Interventions
Oral administration of the investigational product (OM-89 \[Uro-Vaxom® Capsule\] or the placebo) once a day
Oral administration of the investigational product(Placebo of Uro-Vaxom® Capsule)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06345014