Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis

Exclusion Criteria

• •Signs or symptoms of vaginal/cervical/pelvic infection on screening or clinical diagnosis of vaginal/cervical/pelvic infection in the past 14 days.
• •(including but not limited to yeast vulvovaginitis, chlamydia, gonorrhea, trichomonas, genital ulcer disease, pelvic inflammatory disease). Self-treatment for presumed yeast vaginitis is not an exclusion if treatment was discontinued 7 days or greater prior to enrollment
• •* Treatment for BV within the past 14 days
• •* Cervical or vaginal high grade squamous intraepithelial dysplasia (HSIL), atypical glandular cells of uncertain significance (AGUS) or cervical intraepithelial neoplasia grade 2 (CIN2) or higher\*
• •Atypical squamous cells of undetermined significance (ASCUS), low grade squamous intraepithelial lesion (LSIL) or cervical intraepithelial neoplasia grade 1 (CIN1) are acceptable. Individuals with a history of atypical glandular cells of uncertain significance (AGUS), HSIL or CIN2 and who have received subsequent evaluation and/or treatment with follow up normal PAP smear are eligible. Patient report will be accepted
• •* History of undiagnosed vaginal bleeding
• •* Use of a systemic, vaginal, or perineal antibiotic within 7 days prior to enrollment in this study
• •* Use of an immunosuppressive or immunomodulatory drug\* for two or more consecutive weeks within 6 months prior to enrollment
• •such as \>0.5 mg/kg/day or \>/=20 mg total dose/day of prednisone orally or \>800 µg of inhaled beclomethasone (nasal and non-genital topical steroids are allowed)
• •* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Monolaurin Vaginal Gel
• •* Uncontrolled concurrent illness\*. Subjects with a history of organ or marrow transplant are excluded.
• •Including, but not limited to, ongoing or active infection, active liver, kidney or autoimmune diseases (a history of thyroid disease will be permitted as long as the thyroid disease is now stable), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• •* Acute illness within 3 days before receipt of study product (per investigator's discretion)
• •* Pregnant women and women who are planning to become pregnant within 30 days after the final study dose, or women who are breastfeeding
• •* Immunosuppression as a result of an underlying illness or treatment or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months
• •* Active neoplastic disease\* or a history of any hematologic malignancy. Active neoplastic disease is defined as neoplastic disease or treatment for neoplastic disease within the past 5 years
• •(excluding non-melanoma skin cancer)
• •-Received an experimental agent\* within 30 days before receipt of study product or expect to receive an experimental agent during the 1 month study period.
• •(vaccine, drug, biologic, device, blood product, or medication)
• •* Any condition that would place the subject at an unacceptable risk of injury, render her unable to meet the requirements of the protocol, or that may interfere with successful completion of the study
• •* A history of alcohol or drug abuse\* during the previous 1 year that in the opinion of the site investigator would interfere with study procedures
• •For example, daily excessive alcohol use or frequent binge drinking as determined by the investigator, or daily marijuana use