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

Exclusion Criteria

• •Sensitivity to ingredients in the study medications.
• •Subject currently participates in, or has within 30 days prior to this clinical trial participated in, an investigational clinical trial.
• •Subject experienced 4 or more episodes of VVC in the past 12 months.
• •Subjects with other causes of vulvovaginitis.
• •Subjects with active HPV infection.
• •Subjects with other urogenital infections that would potentially alter their response to disease.
• •Subjects with confirmed Neisseria gonorrhea or Chlamydia trachomatis.
• •Subjects with abnormal PAP test results except for ASC-US with confirmed absence of High-Risk HPV infection.
• •Subjects who will be under treatment or have surgery during the study period for cervical intraepithelial neoplasia or cervical carcinoma.
• •Subjects with a planned major surgery during the time of the study.
• •Pregnant or nursing subjects.
• •Subjects menstruating at enrollment.
• •History of hypersensitivity to azoles.
• •Evidence/history of ventricular dysfunction such as congestive heart failure, unstable coronary artery disease, significant cardiac arrhythmias or proarrhythmic conditions associated with prolongation of QT interval.
• •History of clinically significant ECG abnormalities, including QTc prolongation.
• •Current treatment with: erythromycin, astemizole, pimozide, quinidine, and cisapride)
• •History of cancer or currently being treated for a cancer.
• •Subject is immunocompromised or has chronic mucocutaneous candidiasis.
• •Use of systemic immunosuppressants such as cyclosporine, TNF inhibitors and tacrolimus.
• •History of liver toxicity with other drugs.
• •History of hepatic or renal impairment.
• •Subjects with diabetes mellitus with poor glycemic control (HgbA1C \>7%).
• •Subjects with any other concurrent significant uncontrolled illness.
• •Use of oral antifungals within 14 days immediately prior to enrollment.
• •Use of systemic corticosteroids within 30 days immediately prior to enrollment (inhaled corticosteroids are permitted).
• •Use of any topical vaginal products within 1 week prior to enrollment.
• •Subject is a substance abuser such that the abuse may result in lack of study compliance.
• •Vaginal pessaries and rings used for contraception or hormone replacement therapy.
• •Subject used an antibiotic within 24 hours immediately prior to enrollment.