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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01891331
Recruitment Status : Completed
First Posted : July 3, 2013
Last Update Posted : December 24, 2014
Information provided by (Responsible Party):

Brief Summary:
CYP51 is an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of compounds toxic to the fungus. CYP51 is the target of the class of drugs referred to as 'azole antifungals'. The lack of selectivity by the azole antifungals is responsible for many of the side effects associated with these drugs. 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 (oral) Drug: Fluconazole (oral) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Arm Intervention/treatment
Experimental: VT-1161 (oral)
VT-1161 300 mg q.d. for 3 days
Drug: VT-1161 (oral)
Active Comparator: Fluconazole
Fluconazole 150 mg administered orally in a single dose (administered blinded to match the VT-1161 dose regimens)
Drug: Fluconazole (oral)

Primary Outcome Measures :
  1. To evaluate the composite clinical efficacy of oral VT-1161 compared with fluconazole in the treatment of patients with moderate to severe acute vulvovaginal candidiasis [ Time Frame: Test of Cure conducted at baseline (day 1) ]
    Vulvovaginal signs and symptoms will be evaluated at screening/baseline and at test of cure day 28 (Week 4)

  2. To evaluate the composite clinical efficacy of oral VT-1161 compared with oral fluconazole in the treatment of patients with moderate to severe acute vulvovaginal candidiasis [ Time Frame: 4 weeks ]
    Clinical efficacy will be evaluated at screening/baseline (Day 1) and at test-of-cure visit Week 4 (Day 28)

Information from the National Library of Medicine

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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

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

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 identifier (NCT number): NCT01891331

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

Responsible Party: Viamet Identifier: NCT01891331     History of Changes
Other Study ID Numbers: VMT-VT-1161-CL-004
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: December 24, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Candidiasis, Vulvovaginal
Vaginal Diseases
Genital Diseases, Female
Vulvar Diseases
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