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

Completed · Phase 2

Conditions studied: Vulvovaginal Candidiasis

In brief

The primary objective of the study is to evaluate the rate of therapeutic cure of the combination treatment of MGCD290 and fluconazole as compared to that of fluconazole alone at Test of Cure Visit for patients with moderate to severe vulvovaginal candidiasis.

Key facts

Study ID

NCT01497223

Run by

MethylGene Inc.

People needed

220

Starts

2011-12-01

Expected to finish

2013-04-01

Last updated by the study team

2013-04-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 budding yeasts.
• Aged 18 and over, post-menarcheal, and not surgically or naturally post-menopausal.

You may not qualify if…

• 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).

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Women's Health Care Research Corp. — San Diego, California, United States
• Altus Research — Lake Worth, Florida, United States
• Healthcare Clinical Data, Inc. — North Miami, Florida, United States
• Georgia Health Sciences University — Augusta, Georgia, United States
• Clinical Trials Management — Covington, Louisiana, United States
• Clinical Trials Management, LLC — Metairie, Louisiana, United States
• Harper University Hospital — Detroit, Michigan, United States
• Clinical Research of Nevada — Las Vegas, Nevada, United States
• SUNY Downstate Medical Center — Brooklyn, New York, United States
• Lyndhurst Clinical Research — Raleigh, North Carolina, United States
• Lyndhurst Clinical Research — Winston-Salem, North Carolina, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Brownstone Clinical Trials — Irving, Texas, United States
• Physician's Research Options — Sandy City, Utah, United States
• Tidewater Physicians for Women — Norfolk, Virginia, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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