The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Launched by AJU PHARM CO., LTD. · Apr 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called OM-89 for men who suffer from recurrent chronic prostatitis or chronic pelvic pain syndrome. These conditions can cause ongoing pain and discomfort in the pelvic or genital area. The goal of the trial is to see how effective and safe OM-89 is for relieving these symptoms.

To participate in the study, men aged 19 to 55 who have significant pelvic pain (as measured by a specific symptom index) may be eligible. However, there are some health conditions that would exclude someone from joining, such as having a high prostate-specific antigen (PSA) level or a recent history of certain medical treatments. Participants can expect to be closely monitored throughout the trial to assess the treatment's effects and any side effects. This study is currently recruiting participants, and it aims to improve the understanding and management of these challenging conditions.

Gender

MALE

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