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 |
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.
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
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
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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