Clinical trial NCT02267382: A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Vulvovaginal Candidiasis
Lead sponsor: Viamet
Sponsor class: INDUSTRY
First posted: 2014-10-17
Enrollment: 254
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 48 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: San Diego
country: United States
facility: Genesis Center for Clinical Research
state: California
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Miami
country: United States
facility: Healthcare Clinical Data
state: Florida
city: North Miami
country: United States
facility: Community Medical Research
state: Florida
city: Palm Beach
country: United States
facility: Vision Clinical Research
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clinical Research LLC
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Wichita
country: United States
facility: Cypress Medical Research Center
state: Kansas
city: Covington
country: United States
facility: Clinical Trials Management LLC
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management LLC
state: Louisiana
city: Fall River
country: United States
facility: New England Center for Clinical Research
state: Massachusetts
city: Las Vegas
country: United States
facility: Clinical Research of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: R. Garn Mabey, Jr. M.D. Chartered
state: Nevada
city: Lawrenceville
country: United States
facility: OB/GYN Clinical Research
state: New Jersey
city: Plainsboro
country: United States
facility: Women's Health Research Center
state: New Jersey
city: Port Jefferson
country: United States
facility: Suffolk OB-GYN
state: New York
city: Raleigh
country: United States
facility: United Women's Clinical Research-Raleigh
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Akron
country: United States
facility: Radiant Research
state: Ohio
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Women's Hospital
state: Pennsylvania
city: Fort Worth
country: United States
facility: Brownstone Clinical Trials
state: Texas
city: Houston
country: United States
facility: TMC Life Research
state: Texas
city: Irving
country: United States
facility: Brownstone Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Sandy
country: United States
facility: Physician's Research Options LLC
state: Utah
city: Seattle
country: United States
facility: Seattle Women's Health Research Gynecology
state: Washington
Study officials:
References:
citation: Brand 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.