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

NCT ID: NCT01497223

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-04-30

Brief Summary

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.

Detailed Description

MGCD290 is a novel antifungal agent targeting the Hos2 enzyme in fungi. MGCD290 was shown to potentiate and broaden the spectrum of activity of azole antifungal agents in vitro, especially fluconazole. MGCD290 taken together with fluconazole was observed to be safe in healthy volunteer studies. The current study is evaluating both the efficacy and safety of the combination treatment in subjects with moderate to severe vulvovaginal candidiasis.

Conditions

Vulvovaginal Candidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MGCD290 and Fluconazole

Oral Administration of MGCD290 and Fluconazole

Group Type: EXPERIMENTAL

MGCD290

Intervention Type: DRUG

1 Oral Dose Administration

Fluconazole

This is an Active Comparator: Oral Administration of Fluconazole with Placebo

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MGCD290

1 Oral Dose Administration

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MethylGene Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Reid, MSc, MBA

Role: STUDY_DIRECTOR

MethylGene Inc.

Locations

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

Countries

United States

Other Identifiers

290-005

Identifier Type: -

Identifier Source: org_study_id