MGCD290 and Fluconazole Versus Fluconazole Alone for the Treatment of Moderate to Severe Vulvovaginal Candidiasis

Inclusion Criteria: * Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7. * Subject with normal vaginal pH (≤4.5) upon evaluation. * Subject completes the informed consent process. * Subject agrees to take study medication when scheduled. Subject has no difficulty swallowing the medication. * Subject complies with all clinical trial instructions. Commits to all follow-up visits. * Subject is free of any disease or physical condition which might impair the evaluation of safety and/or vulvovaginal candidiasis. * Subject of childbearing potential has a negative urine pregnancy test at screening. * Subject of childbearing potential agrees to use an effective, non-prohibited form of birth control for the duration of clinical trial or until onset of menses following the administration of study medication, whichever is longer. She must be on a stable regimen of oral contraceptives, contraceptive implant or depot injection, contraceptive patch, IUD, condom and spermicidal agent, diaphragm and spermicidal agent, or sexual abstinence for at least the past 60 days. * Subject agrees to abstain from sexual intercourse from the time of randomization through the first seven days immediately following treatment. * Direct microscopic examination with KOH must be positive at screening showing yeast forms (hyphae/pseudohyphae) or…