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A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)

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ClinicalTrials.gov Identifier: NCT01891331
Recruitment Status : Completed
First Posted : July 3, 2013
Results First Posted : July 6, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Viamet

Study Description
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Brief Summary:
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast infection). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this results in many of the side effects associated with the azole antifungals. The safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. VT-1161 has been design to be safer and more active against the fungal species typically responsible for vaginal yeast infections (i.e. vulvovaginal candidiasis).

Condition or disease Intervention/treatment Phase
Candidiasis, Vulvovaginal Drug: VT-1161 Drug: Fluconazole Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2A, Randomized, Double-Blind, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets Compared to Fluconazole in the Treatment of Patients With Moderate to Severe Acute Vulvovaginal Candidiasis
Study Start Date : August 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections
Drug Information available for: Fluconazole

Arms and Interventions
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Arm Intervention/treatment
Experimental: VT-1161 300mg QD Drug: VT-1161
Experimental: VT-1161 600mg QD Drug: VT-1161
Experimental: VT-1161 600mg BID Drug: VT-1161
Active Comparator: Fluconazole 150mg Drug: Fluconazole


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population [ Time Frame: 4 weeks ]

    For this trial, therapeutic cure was defined as mycological AND clinical cure. Mycological cure was defined as a negative fungal culture for Candida species. Clinical cure was defined as all of the following:

    1. complete resolution of signs and symptoms pertaining to vulvovaginal candidiasis;
    2. any new sign or symptom observed at 28 days determined by investigator to not be related to vulvovaginal candidiasis;
    3. no use of any other antifungal drug therapy for treatment of vulvovaginal irritation and/or pruritus by subject.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Females ≥18 and <65 years
  • Clinical diagnosis of symptomatic acute VVC
  • Positive KOH .At least one vulvovaginal sign (vulvovaginal erythema, edema, or excoriation).
  • At least one vulvovaginal symptom (vulvovaginal itching, burning, or irritation)
  • A minimum composite vulvovaginal signs and symptoms score of ≥6
  • must be be able to swallow capsules

Exclusion Criteria:

  • Evidence of major organ system disease
  • History of cervical cancer
  • History of diabetes mellitus
  • Pregnant
  • Recent use of systemic antifungal drugs or systemic antimicrobial therapy for any reason
  • Recent use of drugs to treat vaginal infections
  • Recent use of immunosuppressive therapies
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891331


Locations
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United States, Florida
Altus Research
Lake Worth, Florida, United States, 33461
Healthcare Clinical Data, Inc
North Miami, Florida, United States, 33161
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
Lyndhurst Clinical Research
Raleigh, North Carolina, United States, 27607
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Drexel Vaginitis Center
Philadelphia, Pennsylvania, United States, 19102
United States, Texas
Brownstone Clinical Trials, LLC
Irving, Texas, United States, 75062
United States, Washington
Harborview ID Research Clinic
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Viamet
More Information
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Responsible Party: Viamet
ClinicalTrials.gov Identifier: NCT01891331     History of Changes
Other Study ID Numbers: VMT-VT-1161-CL-004
First Posted: July 3, 2013    Key Record Dates
Results First Posted: July 6, 2018
Last Update Posted: August 1, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases
Fluconazole
Antifungal Agents
 Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors