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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Vulvovaginal Candidiasis
• Intervention / Treatment: Drug: Placebo; Drug: VT-1161

• Study Type: Interventional
• Enrollment (Actual): 254
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Precision Trials
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Clinic
  • California
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials
    • Los Angeles, California, United States, 90017
      • Axis Clinical Trials
    • San Diego, California, United States, 92103
      • Genesis Center for Clinical Research
  • Florida
    • Lake Worth, Florida, United States, 33461
      • Altus Research
    • Miami, Florida, United States, 33161
      • Healthcare Clinical Data
    • North Miami, Florida, United States, 33181
      • COMMUNITY Medical Research
    • Palm Beach, Florida, United States, 33414
      • Vision Clinical Research
    • Sarasota, Florida, United States, 34239
      • Physician Care Clinical Research LLC
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Cypress Medical Research Center
  • Louisiana
    • Covington, Louisiana, United States, 70471
      • Clinical Trials Management LLC
    • Metairie, Louisiana, United States, 70006
      • Clinical Trials Management LLC
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • New England Center for Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Clinical Research of Nevada
    • Las Vegas, Nevada, United States, 89128
      • R. Garn Mabey, Jr. M.D. Chartered
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • OB/GYN Clinical Research
    • Plainsboro, New Jersey, United States, 08536
      • Women's Health Research Center
  • New York
    • Port Jefferson, New York, United States, 11777
      • Suffolk OB-GYN
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • United Women's Clinical Research-Raleigh
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurst Clinical Research
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Women's Hospital
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Brownstone Clinical Trials
    • Houston, Texas, United States, 77054
      • TMC Life Research
    • Irving, Texas, United States, 75062
      • Brownstone Clinical Trials
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas
  • Utah
    • Sandy, Utah, United States, 84020
      • Physician's Research Options LLC
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Women's Health Research Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VT-1161 Low-dose 3-month; 1 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	Drug: VT-1161
Experimental: VT-1161 Low-dose 6-month; 1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks	Drug: VT-1161
Experimental: VT-1161 High-dose 3-month; 2 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	Drug: VT-1161
Experimental: VT-1161 High-dose 24-week; 2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks	Drug: VT-1161
Placebo Comparator: Placebo; 2 placebo tablets once daily for 7 days, then once weekly for 23 weeks	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Viamet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2015
• Primary Completion (Actual): November 9, 2016
• Study Completion (Actual): November 9, 2016

Study Registration Dates

• First Submitted: October 8, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimate): October 17, 2014

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 7, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Recurrence; Candidiasis, Vulvovaginal
• Other Study ID Numbers: VMT-VT-1161-CL-006