Vulvovaginal CandidiasisPhase 2NCT01497223
MGCD290 and Fluconazole Versus Fluconazole Alone for the Treatment of Moderate to Severe Vulvovaginal Candidiasis
A Phase 2 study testing MGCD290 in people with Vulvovaginal Candidiasis, run by MethylGene Inc. at 19 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvovaginal Candidiasis
- What is being tested?
- MGCD290
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 19 sitesUnited States
- Study dates
- Dec 2011to Apr 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Georgia Health Sciences University
Augusta, Georgia, 30912-3500
University of Alabama at Birmingham
Birmingham, Alabama, 35294
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Medical University of South Carolina
Charleston, South Carolina, 29403
Clinical Trials Management
Covington, Louisiana, 70433
Harper University Hospital
Detroit, Michigan, 48201
Brownstone Clinical Trials
Irving, Texas, 75061
Altus Research
Lake Worth, Florida, 33461
Clinical Research of Nevada
Las Vegas, Nevada, 89123
Clinical Trials Management, LLC
Metairie, Louisiana, 70006
Tidewater Physicians for Women
Norfolk, Virginia, 23502
Healthcare Clinical Data, Inc.
North Miami, Florida, 33161
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Lyndhurst Clinical Research
Raleigh, North Carolina, 27607
Women's Health Care Research Corp.
San Diego, California, 92123
Physician's Research Options
Sandy City, Utah, 84070
University of Washington
Seattle, Washington, 98104
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
About this study
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
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.
Read the 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.
- Conditions
- Vulvovaginal Candidiasis
- Being tested
- MGCD290
- Keywords
- Phase II, Double-Blind, Placebo-Controlled, Vulvovaginal Candidiasis, Moderate to Severe, Acute, Treatment of Moderate to Severe Vulvovaginal Candidiasis
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGCD290Drug
1 Oral Dose Administration
| Study group | Role | What they receive |
|---|---|---|
| MGCD290 and Fluconazole | Experimental | Oral Administration of MGCD290 and Fluconazole Receives: Drug: MGCD290 |
| Fluconazole | No intervention | This is an Active Comparator: Oral Administration of Fluconazole with Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Cure Rate
Measured: 28 Days
Secondary outcomes (6)
Mycological Cure Rate
Measured: Day 14 and Day 28
Clinical Cure Rate
Measured: Day 14 and Day 28
Therapeutic Cure Rate
Measured: Day 14
Recurrence Rate
Measured: Day 28
Time to Resolution of Symptoms
Measured: First 14 days post-dose
Improvement in Symptoms
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- MethylGene Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Reid, MSc, MBA, Study director, MethylGene Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497223
- Sponsor's protocol ID
- 290-005
- Status last verified
- Jun 2012
- First submitted
- 20 Dec 2011
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01497223
- Acronym / sponsor ID
- 290-005
- Conditions
- Vulvovaginal Candidiasis
- Keywords
- Phase II, Double-Blind, Placebo-Controlled, Vulvovaginal Candidiasis, Moderate to Severe, Acute, Treatment of Moderate to Severe Vulvovaginal Candidiasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- MethylGene Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 22 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MGCD290 and Fluconazole | Experimental | Drug: MGCD290Oral Administration of MGCD290 and Fluconazole |
| Fluconazole | No intervention | –This is an Active Comparator: Oral Administration of Fluconazole with Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGCD2901 Oral Dose Administration | Drug | MGCD290 and Fluconazole |
Primary outcome
Therapeutic Cure Rate
Time frame: 28 Days
6 secondary outcomes
Mycological Cure Rate
Time frame: Day 14 and Day 28
Clinical Cure Rate
Time frame: Day 14 and Day 28
Therapeutic Cure Rate
Time frame: Day 14
Recurrence Rate
Time frame: Day 28
Time to Resolution of Symptoms
Time frame: First 14 days post-dose
Improvement in Symptoms
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Reid, MSc, MBA study director
MethylGene Inc.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MGCD290 in people with Vulvovaginal Candidiasis, run by MethylGene Inc. at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic Cure Rate (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.