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



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 65
Updated:12/16/2017
Start Date:February 10, 2015
End Date:November 9, 2016

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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

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.


Key Inclusion Criteria:

Clinical diagnosis of symptomatic acute VVC

3 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

Key Exclusion Criteria:

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
We found this trial at
32
sites
Metairie, Louisiana 70006
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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4671 S. Congress Ave.
Lake Worth, Florida 33461
561-641-0404
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Lake Worth, FL
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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Akron, Ohio 44311
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Covington, Louisiana
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Fall River, Massachusetts 02720
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Fort Worth, Texas
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Houston, Texas 77054
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Irving, Texas 75061
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Jonesboro, Arkansas 72401
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Las Vegas, Nevada
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Las Vegas, Nevada 89128
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Lawrenceville, New Jersey
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Los Angeles, California 90036
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Los Angeles, California 90036
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Miami, Florida
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North Miami, Florida 33181
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Palm Beach, Florida
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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Philadelphia, PA
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Phoenix, Arizona 85032
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Pittsburgh, Pennsylvania 15213
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Plainsboro, New Jersey 08536
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Port Jefferson, New York 11777
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Raleigh, North Carolina 27607
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San Diego, California 92103
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Sandy, Utah 84070
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Sarasota, Florida 34321
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5115 North Armenia Avenue
Tampa, Florida 33603
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Wichita, Kansas 67226
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Winston-Salem, North Carolina 27103
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