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

Vulvovaginal Candidiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497223
• Other study ID #: 290-005
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2011
• Last updated: April 2, 2013
• Start date: December 2011
• Est. completion date: April 2013

Study information

• Verified date: June 2012
• Source: MethylGene Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiasis

Intervention

Drug:
• MGCD290
1 Oral Dose Administration

Locations

Country	Name	City	State
United States	Georgia Health Sciences University	Augusta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Clinical Trials Management	Covington	Louisiana
United States	Harper University Hospital	Detroit	Michigan
United States	Brownstone Clinical Trials	Irving	Texas
United States	Altus Research	Lake Worth	Florida
United States	Clinical Research of Nevada	Las Vegas	Nevada
United States	Clinical Trials Management, LLC	Metairie	Louisiana
United States	Tidewater Physicians for Women	Norfolk	Virginia
United States	Healthcare Clinical Data, Inc.	North Miami	Florida
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania
United States	Lyndhurst Clinical Research	Raleigh	North Carolina
United States	Women's Health Care Research Corp.	San Diego	California
United States	Physician's Research Options	Sandy	Utah
United States	University of Washington	Seattle	Washington
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
MethylGene Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic Cure Rate		28 Days	No
Secondary	Mycological Cure Rate		Day 14 and Day 28	No
Secondary	Clinical Cure Rate		Day 14 and Day 28	No
Secondary	Therapeutic Cure Rate		Day 14	No
Secondary	Recurrence Rate		Day 28	No
Secondary	Time to Resolution of Symptoms		First 14 days post-dose	No
Secondary	Improvement in Symptoms		Day 14	No