A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Acute Vaginal Candidiasis (Yeast Infection)
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ClinicalTrials.gov Identifier: NCT01891331 |
Recruitment Status
:
Completed
First Posted
: July 3, 2013
Last Update Posted
: December 24, 2014
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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 |

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) |
- 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)
- 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)

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

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
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 |
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 |
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 |