A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in 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. |
ClinicalTrials.gov Identifier: NCT01891331 |
Recruitment Status :
Completed
First Posted : July 3, 2013
Results First Posted : July 6, 2018
Last Update Posted : August 1, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Candidiasis, Vulvovaginal | Drug: VT-1161 Drug: Fluconazole | Phase 2 |
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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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

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 |
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 |
Candidiasis Candidiasis, Vulvovaginal Mycoses Bacterial Infections and Mycoses Infections Vulvovaginitis Vaginitis Vaginal Diseases 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 |