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

Recurrent Vulvovaginal Candidiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267382
• Other study ID #: VMT-VT-1161-CL-006
• Status: Completed
• Phase: Phase 2
• Start date: February 10, 2015
• Est. completion date: November 9, 2016

Study information

• Verified date: October 2019
• Source: Viamet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: November 9, 2016
• Est. primary completion date: November 9, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Recurrent Vulvovaginal Candidiasis

Intervention

Drug:
• VT-1161

• Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Viamet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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); = mild (slight); = moderate (definitely present); = severe (marked, intense)	48 Weeks