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

NCT01497223 | Completed Phase 2

• 1 other identifier: 290-005
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 19

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.

Conditions

Vulvovaginal Candidiasis

Keywords

Phase II; Double-Blind; Placebo-Controlled; Vulvovaginal Candidiasis; Moderate to Severe; Acute; Treatment of Moderate to Severe Vulvovaginal Candidiasis

Outcome Measures

Primary Outcomes (1)

• Therapeutic Cure Rate

  28 Days

Secondary Outcomes (6)

• Mycological Cure Rate

  Day 14 and Day 28

• Clinical Cure Rate

  Day 14 and Day 28

• Therapeutic Cure Rate

  Day 14

• Recurrence Rate

  Day 28

• Time to Resolution of Symptoms

  First 14 days post-dose

Study Arms (2)

MGCD290 and Fluconazole

EXPERIMENTAL

Oral Administration of MGCD290 and Fluconazole

Drug: MGCD290

Fluconazole

NO INTERVENTION

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

Interventions

MGCD290 DRUG

1 Oral Dose Administration

MGCD290 and Fluconazole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• MethylGene Inc.: lead

Study Sites (19)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Women's Health Care Research Corp.

San Diego, California, 92123, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

Healthcare Clinical Data, Inc.

North Miami, Florida, 33161, United States

Location

Georgia Health Sciences University

Augusta, Georgia, 30912-3500, United States

Location

Clinical Trials Management

Covington, Louisiana, 70433, United States

Location

Clinical Trials Management, LLC

Metairie, Louisiana, 70006, United States

Location

Harper University Hospital

Detroit, Michigan, 48201, United States

Location

Clinical Research of Nevada

Las Vegas, Nevada, 89123, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Lyndhurst Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Brownstone Clinical Trials

Irving, Texas, 75061, United States

Location

Physician's Research Options

Sandy City, Utah, 84070, United States

Location

Tidewater Physicians for Women

Norfolk, Virginia, 23502, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Officials

• Gregory Reid, MSc, MBA

  MethylGene Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 22, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 4, 2013

Record last verified: 2012-06

Locations

US (19)