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A Study of Oral VT-1161 for the Treatment of Acute Vaginal Candidiasis (Yeast Infection) in Patients With Recurrent Vaginal Candidiasis (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 : Active, not recruiting
First Posted : February 15, 2019
Last Update Posted : September 2, 2020
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
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE March 13, 2019
Estimated Primary Completion Date November 20, 2020   (Final data collection date for primary outcome measure)
Current 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Oral VT-1161 for the Treatment of Acute Vaginal Candidiasis (Yeast Infection) in Patients With Recurrent Vaginal Candidiasis
Official Title  ICMJE A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of VT-1161 Oral Capsules Versus Fluconazole and Placebo in the Treatment of Acute Vulvovaginal Candidiasis Episodes 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 VVC in the past 12 months. Several properties of 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 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 period for the treatment of the patient's current VVC episode when the patient will take either fluconazole or VT-1161 (according to a random assignment). The second part consists of 11 weeks, when the patient will take either 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: VT-1161 150 mg capsule
    During Part 1, administered orally once daily for 2 days. During Part 2, administered orally once weekly for 11 weeks starting on Day 14.
  • Drug: Fluconazole 150 mg
    During Part 1, administered orally 3 sequential doses (every 72 hours).
  • Other: Placebo
    During Part 2, administered orally once weekly for 11 weeks starting on Day 14.
Study Arms  ICMJE
  • Experimental: VT-1161 150 mg capsule
    Intervention: Drug: VT-1161 150 mg capsule
  • Active Comparator: Fluconazole 150 mg
    Interventions:
    • Drug: Fluconazole 150 mg
    • Other: 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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 11, 2019)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 20, 2020
Estimated Primary Completion Date November 20, 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
  • 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
Responsible Party Mycovia Pharmaceuticals Inc.
Study Sponsor  ICMJE Mycovia Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mycovia Pharmaceuticals Inc.
Verification Date August 2020

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