A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Recurrent Vulvovaginal Candidiasis
1 other identifier
interventional
254
1 country
32
Brief Summary
VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161 is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect profile that limits the use of commonly prescribed antifungal agents for the treatment of recurrent yeast infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2015
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2014
CompletedFirst Posted
Study publicly available on registry
October 17, 2014
CompletedStudy Start
First participant enrolled
February 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2016
CompletedResults Posted
Study results publicly available
October 4, 2019
CompletedOctober 15, 2019
October 1, 2019
1.7 years
October 8, 2014
September 10, 2019
October 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population.
A culture-verified acute VVC episode was defined as a positive fungal culture for Candida species associated with a clinical signs and symptoms score of ≥3. To calculate the 'signs and symptoms' score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with higher scores indicating a worse outcome. 0 = none (complete absence of any sign or symptom) 1. = mild (slight) 2. = moderate (definitely present) 3. = severe (marked, intense)
48 Weeks
Study Arms (5)
VT-1161 Low-dose 3-month
EXPERIMENTAL1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
VT-1161 Low-dose 6-month
EXPERIMENTAL1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks
VT-1161 High-dose 3-month
EXPERIMENTAL2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
VT-1161 High-dose 24-week
EXPERIMENTAL2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
Placebo
PLACEBO COMPARATOR2 placebo tablets once daily for 7 days, then once weekly for 23 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of symptomatic acute VVC
- or more episodes of acute VVC in the past 12 months
- Positive KOH
- Minimum composite vulvovaginal signs and symptoms score of ≥3 at Screening
- Composite vulvovaginal signs and symptoms score of \<3 at Baseline
- Must be able to swallow tablets
You may not qualify if:
- Evidence of major organ system disease
- Presence or a history of another vaginal or vulvar condition(s)
- History of cervical cancer
- Poorly controlled diabetes mellitus
- Pregnant
- Recent use of topical or systemic antifungal drugs
- Recent use of immunosuppressive or system corticosteroid therapies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viametlead
Study Sites (32)
University of Alabama Birmingham
Birmingham, Alabama, 35233, United States
Precision Trials
Phoenix, Arizona, 85032, United States
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
Axis Clinical Trials
Los Angeles, California, 90017, United States
Axis Clinical Trials
Los Angeles, California, 90036, United States
Genesis Center for Clinical Research
San Diego, California, 92103, United States
Altus Research
Lake Worth, Florida, 33461, United States
Healthcare Clinical Data
Miami, Florida, 33161, United States
Community Medical Research
North Miami, Florida, 33181, United States
Vision Clinical Research
Palm Beach, Florida, 33414, United States
Physician Care Clinical Research LLC
Sarasota, Florida, 34239, United States
Clinical Research of West Florida
Tampa, Florida, 33603, United States
Cypress Medical Research Center
Wichita, Kansas, 67226, United States
Clinical Trials Management LLC
Covington, Louisiana, 70471, United States
Clinical Trials Management LLC
Metairie, Louisiana, 70006, United States
New England Center for Clinical Research
Fall River, Massachusetts, 02720, United States
Clinical Research of Nevada
Las Vegas, Nevada, 89123, United States
R. Garn Mabey, Jr. M.D. Chartered
Las Vegas, Nevada, 89128, United States
OB/GYN Clinical Research
Lawrenceville, New Jersey, 08648, United States
Women's Health Research Center
Plainsboro, New Jersey, 08536, United States
Suffolk OB-GYN
Port Jefferson, New York, 11777, United States
United Women's Clinical Research-Raleigh
Raleigh, North Carolina, 27607, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
Radiant Research
Akron, Ohio, 44311, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213, United States
Brownstone Clinical Trials
Fort Worth, Texas, 76104, United States
TMC Life Research
Houston, Texas, 77054, United States
Brownstone Clinical Trials
Irving, Texas, 75062, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Physician's Research Options LLC
Sandy City, Utah, 84020, United States
Seattle Women's Health Research Gynecology
Seattle, Washington, 98105, United States
Related Publications (2)
Vanreppelen G, Nysten J, Baldewijns S, Sillen M, Donders G, Van Dijck P. Oteseconazole (VIVOJA) for prevention of recurrent vulvovaginal candidiasis. Trends Pharmacol Sci. 2023 Jan;44(1):64-65. doi: 10.1016/j.tips.2022.10.004. Epub 2022 Nov 14. No abstract available.
PMID: 36396498DERIVEDBrand SR, Degenhardt TP, Person K, Sobel JD, Nyirjesy P, Schotzinger RJ, Tavakkol A. A phase 2, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of orally administered VT-1161 in the treatment of recurrent vulvovaginal candidiasis. Am J Obstet Gynecol. 2018 Jun;218(6):624.e1-624.e9. doi: 10.1016/j.ajog.2018.03.001. Epub 2018 Mar 11.
PMID: 29534874DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr Vice President, Clinical Development
- Organization
- Mycovia Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2014
First Posted
October 17, 2014
Study Start
February 10, 2015
Primary Completion
November 9, 2016
Study Completion
November 9, 2016
Last Updated
October 15, 2019
Results First Posted
October 4, 2019
Record last verified: 2019-10