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

Primary Purpose

Vulvovaginal Candidiasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MGCD290
Sponsored by
MethylGene Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvovaginal Candidiasis focused on measuring Phase II, Double-Blind, Placebo-Controlled, Vulvovaginal Candidiasis, Moderate to Severe, Acute, Treatment of Moderate to Severe Vulvovaginal Candidiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Women's Health Care Research Corp.
  • Altus Research
  • Healthcare Clinical Data, Inc.
  • Georgia Health Sciences University
  • Clinical Trials Management
  • Clinical Trials Management, LLC
  • Harper University Hospital
  • Clinical Research of Nevada
  • SUNY Downstate Medical Center
  • Lyndhurst Clinical Research
  • Lyndhurst Clinical Research
  • Drexel University College of Medicine
  • Magee-Womens Hospital of UPMC
  • Medical University of South Carolina
  • Brownstone Clinical Trials
  • Physician's Research Options
  • Tidewater Physicians for Women
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MGCD290 and Fluconazole

Fluconazole

Arm Description

Oral Administration of MGCD290 and Fluconazole

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

Outcomes

Primary Outcome Measures

Therapeutic Cure Rate

Secondary Outcome Measures

Mycological Cure Rate
Clinical Cure Rate
Therapeutic Cure Rate
Recurrence Rate
Time to Resolution of Symptoms
Improvement in Symptoms

Full Information

First Posted
December 20, 2011
Last Updated
April 2, 2013
Sponsor
MethylGene Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01497223
Brief Title
MGCD290 and Fluconazole Versus Fluconazole Alone for the Treatment of Moderate to Severe Vulvovaginal Candidiasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MethylGene Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Candidiasis
Keywords
Phase II, Double-Blind, Placebo-Controlled, Vulvovaginal Candidiasis, Moderate to Severe, Acute, Treatment of Moderate to Severe Vulvovaginal Candidiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MGCD290 and Fluconazole
Arm Type
Experimental
Arm Description
Oral Administration of MGCD290 and Fluconazole
Arm Title
Fluconazole
Arm Type
No Intervention
Arm Description
This is an Active Comparator: Oral Administration of Fluconazole with Placebo
Intervention Type
Drug
Intervention Name(s)
MGCD290
Intervention Description
1 Oral Dose Administration
Primary Outcome Measure Information:
Title
Therapeutic Cure Rate
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Mycological Cure Rate
Time Frame
Day 14 and Day 28
Title
Clinical Cure Rate
Time Frame
Day 14 and Day 28
Title
Therapeutic Cure Rate
Time Frame
Day 14
Title
Recurrence Rate
Time Frame
Day 28
Title
Time to Resolution of Symptoms
Time Frame
First 14 days post-dose
Title
Improvement in Symptoms
Time Frame
Day 14

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Reid, MSc, MBA
Organizational Affiliation
MethylGene Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Women's Health Care Research Corp.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Healthcare Clinical Data, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Georgia Health Sciences University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-3500
Country
United States
Facility Name
Clinical Trials Management
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Harper University Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Clinical Research of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Lyndhurst Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Brownstone Clinical Trials
City
Irving
State/Province
Texas
ZIP/Postal Code
75061
Country
United States
Facility Name
Physician's Research Options
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Tidewater Physicians for Women
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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

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