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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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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)

Outcome Measures

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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)

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (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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Locations

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Additional relevant MeSH terms:

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