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Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections (ultraVIOLET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03840616
Recruitment Status : Completed
First Posted : February 15, 2019
Results First Posted : February 4, 2022
Last Update Posted : February 4, 2022
Sponsor:
Information provided by (Responsible Party):
Mycovia Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE February 11, 2019
First Posted Date  ICMJE February 15, 2019
Results First Submitted Date  ICMJE November 29, 2021
Results First Posted Date  ICMJE February 4, 2022
Last Update Posted Date February 4, 2022
Actual Study Start Date  ICMJE March 13, 2019
Actual Primary Completion Date December 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2021)
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: 48 Weeks ]
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, which includes subjects who failed to clear their initial acute VVC episode during the induction phase. 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)
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2019)
Percentage of subjects with one or more culture-verified acute VVC episodes [ Time Frame: 50 Weeks ]
An acute VVC episode (considered a recurrent episode) is defined as a positive culture for Candida species and a clinical signs and symptoms score of ≥3. Outcome measure includes subjects who failed clearing their initial acute VVC episode during Part 1.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2019)
Percentage of subjects with resolved acute VVC episodes during Part 1 [ Time Frame: 14 Days ]
Resolution of the acute VVC episode is defined as a clinical signs and symptoms score of <3 at Day 14.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections
Official Title  ICMJE Phase 3, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules vs Fluconazole and Placebo in Treatment of Acute Vulvovaginal Candidiasis in Subjects With Recurrent Vulvovaginal Candidiasis
Brief Summary

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

This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the treatment of acute VVC episodes in patients with RVVC and consists of 2 parts. The first part of the study is a 2-week induction phase for the treatment of the patient's current VVC episode when the patient will take either fluconazole or oteseconazole (VT-1161) according to a random assignment. The second part consists of an 11-week maintenance phase, when the patient will take either oteseconazole (VT-1161) or a placebo according to the random assignment from the first part of the study, and then a 37-week follow-up period.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Vulvovaginal Candidiasis
Intervention  ICMJE
  • Drug: Oteseconazole (VT-1161) 150mg capsule
    600mg administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14.
  • Drug: Fluconazole 150mg capsule
    150mg administered every 72 hours in 3 sequential doses starting on Day 1.
  • Drug: Placebo
    Administered once weekly starting on Day 14.
Study Arms  ICMJE
  • Experimental: Oteseconazole (VT-1161) 150mg capsule
    600mg oteseconazole administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14
    Intervention: Drug: Oteseconazole (VT-1161) 150mg capsule
  • Active Comparator: Fluconazole 150mg capsule / Placebo
    150mg fluconazole administered every 72 hours in 3 sequential doses starting on Day 1, followed by placebo administered once weekly starting on Day 14
    Interventions:
    • Drug: Fluconazole 150mg capsule
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2021)
219
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2019)
180
Actual Study Completion Date  ICMJE December 2, 2020
Actual Primary Completion Date December 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 3 or more episodes of acute VVC in the past 12 months
  • Positive KOH test
  • Total vulvovaginal signs and symptoms score of ≥3 at screening visit
  • Total vulvovaginal signs and symptoms score of <3 at Day 14
  • Must be able to swallow pills

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03840616
Other Study ID Numbers  ICMJE VMT-VT-1161-CL-017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mycovia Pharmaceuticals Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mycovia Pharmaceuticals Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mycovia Pharmaceuticals Inc.
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP