A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) (VIOLET)

January 29, 2026 updated by: Mycovia Pharmaceuticals Inc.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules in the Treatment of Subjects With Recurrent Vulvovaginal Candidiasis

Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute VVC in the past 12 months. Several properties of oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for RVVC than other oral antifungal medicines.

This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the treatment of RVVC and consists of 2 parts. The first part of the study is a 2-week period for the treatment of the patient's current VVC episode with 3 150mg doses of fluconazole. The 2nd part consists of 12 weeks, when the patient will take either oteseconazole (VT-1161) 150 mg or a placebo (according to a random assignment), and then a 36-week follow-up period.

In addition, at participating sites, an amendment to the study allows US patients who complete the initial 48 weeks without experiencing a confirmed RVVC episode to continue in a 48-week observational extension period designed to evaluate the continued effectiveness of oteseconazole (VT-1161).

This study is identical to VMT-VT-1161-CL-011.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

425

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • 31215
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • 31227
    • California
      • Los Angeles, California, United States, 90057
        • 31217
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • 31240
    • Florida
      • Homestead, Florida, United States, 33030
        • 31204
      • North Bay Village, Florida, United States, 33141
        • 31233
    • Kansas
      • Wichita, Kansas, United States, 67226
        • 31255
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • 31245
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • 31223
    • Ohio
      • Columbus, Ohio, United States, 43213
        • 31244
      • Columbus, Ohio, United States, 43231
        • 31229
      • Englewood, Ohio, United States, 45322
        • 31222
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • 31218
    • Texas
      • Frisco, Texas, United States, 75035
        • 31232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 3 or more episodes of acute VVC in the past 12 months
  • Positive KOH or Gram stain test
  • Total vulvovaginal signs and symptoms score of ≥3 at screening visit
  • Total vulvovaginal signs and symptoms score of <3 at baseline visit
  • Must be able to swallow pills

Key Exclusion Criteria:

  • Presence or a history of another vaginal or vulvar condition(s)
  • Evidence of major organ system disease
  • History of cervical cancer
  • Poorly controlled diabetes mellitus
  • Pregnant
  • Recent use of topical or systemic antifungal or antibacterial drugs
  • Recent use of immunosuppressive or systemic corticosteroid therapies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oteseconazole (VT-1161) 150mg capsule
Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks
Drug: Oteseconazole (VT-1161)
Oteseconazole (VT-1161) 150mg capsule
Placebo Comparator: Placebo capsule
Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks
Drug: Placebo
matching placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population.
Time Frame: Maintenance phase (Baseline through Week 48)

The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and 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 a higher score indicating a worse outcome.

0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense)
Maintenance phase (Baseline through Week 48)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mycovia Pharmaceuticals Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2018

Primary Completion (Actual)

October 13, 2020

Study Completion (Actual)

August 3, 2021

Study Registration Dates

First Submitted

June 1, 2018

First Submitted That Met QC Criteria

June 18, 2018

First Posted (Actual)

June 19, 2018

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VMT-VT-1161-CL-012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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