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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MethylGene Inc.
ClinicalTrials.gov Identifier:
NCT01497223
First received: December 20, 2011
Last updated: April 2, 2013
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Vulvovaginal Candidiasis
Drug: MGCD290
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Fluconazole Versus Fluconazole And MGCD290 for the Treatment of Moderate to Severe Vulvovaginal Candidiasis

Resource links provided by NLM:


Further study details as provided by MethylGene Inc.:

Primary Outcome Measures:
  • Therapeutic Cure Rate [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mycological Cure Rate [ Time Frame: Day 14 and Day 28 ] [ Designated as safety issue: No ]
  • Clinical Cure Rate [ Time Frame: Day 14 and Day 28 ] [ Designated as safety issue: No ]
  • Therapeutic Cure Rate [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Recurrence Rate [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Time to Resolution of Symptoms [ Time Frame: First 14 days post-dose ] [ Designated as safety issue: No ]
  • Improvement in Symptoms [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: December 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MGCD290 and Fluconazole
Oral Administration of MGCD290 and Fluconazole
Drug: MGCD290
1 Oral Dose Administration
No Intervention: Fluconazole
This is an Active Comparator: Oral Administration of Fluconazole with Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497223

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Women's Health Care Research Corp.
San Diego, California, United States, 92123
United States, Florida
Altus Research
Lake Worth, Florida, United States, 33461
Healthcare Clinical Data, Inc.
North Miami, Florida, United States, 33161
United States, Georgia
Georgia Health Sciences University
Augusta, Georgia, United States, 30912-3500
United States, Louisiana
Clinical Trials Management
Covington, Louisiana, United States, 70433
Clinical Trials Management, LLC
Metairie, Louisiana, United States, 70006
United States, Michigan
Harper University Hospital
Detroit, Michigan, United States, 48201
United States, Nevada
Clinical Research of Nevada
Las Vegas, Nevada, United States, 89123
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
Lyndhurst Clinical Research
Raleigh, North Carolina, United States, 27607
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
United States, Texas
Brownstone Clinical Trials
Irving, Texas, United States, 75061
United States, Utah
Physician's Research Options
Sandy, Utah, United States, 84070
United States, Virginia
Tidewater Physicians for Women
Norfolk, Virginia, United States, 23502
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
MethylGene Inc.
Investigators
Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
  More Information

No publications provided

Responsible Party: MethylGene Inc.
ClinicalTrials.gov Identifier: NCT01497223     History of Changes
Other Study ID Numbers: 290-005
Study First Received: December 20, 2011
Last Updated: April 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by MethylGene Inc.:
Phase II
Double-Blind
Placebo-Controlled
Vulvovaginal Candidiasis
Moderate to Severe
Acute
Treatment of Moderate to Severe Vulvovaginal Candidiasis

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases
Fluconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014