Clinical Research Directory

Inclusion Criteria: * Diagnosed with bacterial vaginosis, defined by Nugent score ≥ 7, at Screening. * Clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the site PI or designee. * Negative testing for sexually transmitted infections (STIs) that would require antibiotic treatment (STIs: syphilis, trichomonas, gonorrhea, chlamydia) at Screening. * Not pregnant at Screening and Enrollment. * Regular menstrual cycles or on stable hormonal contraception. Exclusion Criteria: * Positive for Candida spp. by microscopy, culture, or nucleic acid-based testing at screening and not willing to receive concurrent oral antifungal treatment. * Participants who have undergone hysterectomy (total or supracervical) or trachelectomy. * History of 1. Cancer of the female reproductive tract 2. Uncontrolled recurrent genital herpes simplex infection, defined by at least 1 active episode in the past 6 months. 3. Significant coronary artery disease, myocardial infarction, chronic obstructive pulmonary disease, chronic renal failure, decompensated cirrhosis, or any other condition that in the opinion of the site PI or designee will compromise ability to participate in the study. 4. Any disease that may require genital corticosteroid administration during the study period. Inhaled, intranasal, and topical corticosteroids for other parts of the body are allowed. 5. Regular heavy menstrual bleeding to an extent that may interfere with study product use or protocol specified assessments, in the judgement of the investigator * History of autoimmune disease including, but not limited to, Hashimoto's thyroiditis, pernicious anemia, Addison's disease, rheumatoid arthritis, lupus, multiple sclerosis, myasthenia gravis, Grave's disease, celiac disease, sprue, psoriasis, sarcoidosis, scleroderma, diabetes mellitus, etc. Evidence of autoimmune disease or receiving immunosuppressive therapy at the discretion of site PI or designee. * Vaginal cleansing practices within 7 days prior to dosing. * Patients with human immunodeficiency virus (HIV) infection, regardless of treatment status. * History of severe allergic or anaphylactic reactions, or sensitivity to the IP, its constituents, or metronidazole. * Use of a hormonal vaginal ring device. * Vital signs with systolic blood pressure \> 180 mm/Hg or diastolic blood pressure \> 110 mm/Hg at Screening.