Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis

Exclusion Criteria

• •Intolerance or hypersensitivity to any amphotericin B (AMB) product or to azole antifungal drugs
• •Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections requiring antifungal therapy
• •Received antifungal treatment for VVC within past 10 days except fluconazole, subjects must discontinue fluconazole after informed consent
• •Has another cause or suspected cause of vulvovaginitis
• •Has active HPV
• •Has other urogenital infection
• •Has other vaginal or vulvar condition that would confound interpretation of clinical response
• •Has significant laboratory abnormality at screening
• •Has Type I diabetes, use of insulin, HbA1c\>10
• •Exposure to any investigational product within 30 days of screening
• •Has other condition that would interfere with subject ability to provide informed consent or put subject at undue risk