Clinical Protocol CERN Feasibility Study

Launched by CERN CORPORATION · Apr 10, 2025

Keywords

ClinConnect Summary

The Clinical Protocol CERN Feasibility Study is a research trial aimed at finding out if a new intravaginal device can effectively treat bacterial vaginosis and fungal vaginal infections in premenopausal women. The study will also look at how safe the device is for participants. To do this, the researchers want to know if the device helps resolve symptoms and if tests show that the infections are gone after treatment. Women who qualify for the study will need to have confirmed symptoms of these infections and will use the device for five days. They will also have regular check-ins through phone calls and in-person visits, and they will keep a diary to track their experiences.

To be eligible for this trial, participants must be premenopausal and have a confirmed diagnosis of bacterial vaginosis or fungal vaginitis. However, women who are postmenopausal, currently using other intravaginal devices, or have certain medical conditions or allergies will not be able to participate. This study is currently recruiting participants, and it's a great opportunity for eligible women to contribute to important research that could lead to new treatment options.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Confirm symptomatic and laboratory-confirmed bacterial vaginosis or fungal vaginitis
• Exclusion Criteria:
• • Postmenopausal status, current use of intravaginal devices, concurrent medical therapy for fungal vaginitis or bacterial vaginosis, recent medical therapy for vaginitis in past 7 days, immunosuppressive medication ≤ 3 months before screening, radiation therapy ≤ 3 months before screening, known allergy to curcumin, acrylic, or silicone, major organ disease or clinically significant infection or conditions that may affect clinical assessment of vaginitis, pregnancy or plans for pregnancy, history of intolerance to intravaginal devices, symptomatic pelvic organ prolapse stage 2 or greater.