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

April 2, 2013 updated by: MethylGene Inc.

A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Fluconazole Versus Fluconazole And MGCD290 for the Treatment of Moderate to Severe Vulvovaginal Candidiasis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Therapeutic Cure Rate
Time Frame: 28 Days
28 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mycological Cure Rate
Time Frame: Day 14 and Day 28
Day 14 and Day 28
Clinical Cure Rate
Time Frame: Day 14 and Day 28
Day 14 and Day 28
Therapeutic Cure Rate
Time Frame: Day 14
Day 14
Recurrence Rate
Time Frame: Day 28
Day 28
Time to Resolution of Symptoms
Time Frame: First 14 days post-dose
First 14 days post-dose
Improvement in Symptoms
Time Frame: Day 14
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MethylGene Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gregory Reid, MSc, MBA, MethylGene Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 290-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings