A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)
Public ClinicalTrials.gov record NCT01891331. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01891331
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 55 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2013
- Primary completion
- Nov 30, 2014
- Completion
- Nov 30, 2014
- Last update posted
- Jul 31, 2018
2013 – 2014
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Altus Research | Lake Worth | Florida | 33461 | — |
| Healthcare Clinical Data, Inc | North Miami | Florida | 33161 | — |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | — |
| Lyndhurst Clinical Research | Raleigh | North Carolina | 27607 | — |
| Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| Drexel Vaginitis Center | Philadelphia | Pennsylvania | 19102 | — |
| Brownstone Clinical Trials, LLC | Irving | Texas | 75062 | — |
| Harborview ID Research Clinic | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01891331, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 31, 2018 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01891331 live on ClinicalTrials.gov.