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

Primary Purpose

Recurrent Vulvovaginal Candidiasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VT-1161
Placebo
Sponsored by
Viamet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Vulvovaginal Candidiasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama Birmingham
  • Precision Trials
  • NEA Baptist Clinic
  • Axis Clinical Trials
  • Axis Clinical Trials
  • Genesis Center for Clinical Research
  • Altus Research
  • Healthcare Clinical Data
  • Community Medical Research
  • Vision Clinical Research
  • Physician Care Clinical Research LLC
  • Clinical Research of West Florida
  • Cypress Medical Research Center
  • Clinical Trials Management LLC
  • Clinical Trials Management LLC
  • New England Center for Clinical Research
  • Clinical Research of Nevada
  • R. Garn Mabey, Jr. M.D. Chartered
  • OB/GYN Clinical Research
  • Women's Health Research Center
  • Suffolk OB-GYN
  • United Women's Clinical Research-Raleigh
  • Lyndhurst Clinical Research
  • Radiant Research
  • Drexel University College of Medicine
  • Magee Women's Hospital
  • Brownstone Clinical Trials
  • TMC Life Research
  • Brownstone Clinical Trials
  • Clinical Trials of Texas
  • Physician's Research Options LLC
  • Seattle Women's Health Research Gynecology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

VT-1161 Low-dose 3-month

VT-1161 Low-dose 6-month

VT-1161 High-dose 3-month

VT-1161 High-dose 24-week

Placebo

Arm Description

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

1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks

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

2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks

2 placebo tablets once daily for 7 days, then once weekly for 23 weeks

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
October 8, 2014
Last Updated
October 7, 2019
Sponsor
Viamet
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1. Study Identification

Unique Protocol Identification Number
NCT02267382
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 10, 2015 (Actual)
Primary Completion Date
November 9, 2016 (Actual)
Study Completion Date
November 9, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viamet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Vulvovaginal Candidiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VT-1161 Low-dose 3-month
Arm Type
Experimental
Arm Description
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
Arm Title
VT-1161 Low-dose 6-month
Arm Type
Experimental
Arm Description
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks
Arm Title
VT-1161 High-dose 3-month
Arm Type
Experimental
Arm Description
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
Arm Title
VT-1161 High-dose 24-week
Arm Type
Experimental
Arm Description
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 placebo tablets once daily for 7 days, then once weekly for 23 weeks
Intervention Type
Drug
Intervention Name(s)
VT-1161
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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.
Description
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)
Time Frame
48 Weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Precision Trials
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Genesis Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Healthcare Clinical Data
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Community Medical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33181
Country
United States
Facility Name
Vision Clinical Research
City
Palm Beach
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Physician Care Clinical Research LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Cypress Medical Research Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Clinical Trials Management LLC
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70471
Country
United States
Facility Name
Clinical Trials Management LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
New England Center for Clinical Research
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Clinical Research of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
R. Garn Mabey, Jr. M.D. Chartered
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
OB/GYN Clinical Research
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Women's Health Research Center
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
Country
United States
Facility Name
Suffolk OB-GYN
City
Port Jefferson
State/Province
New York
ZIP/Postal Code
11777
Country
United States
Facility Name
United Women's Clinical Research-Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Radiant Research
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Magee Women's Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Brownstone Clinical Trials
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
TMC Life Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Brownstone Clinical Trials
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Clinical Trials of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Physician's Research Options LLC
City
Sandy
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Seattle Women's Health Research Gynecology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29534874
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.
Results Reference
derived

Learn more about this trial

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

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