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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03562156
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Mycovia Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE June 1, 2018
First Posted Date  ICMJE June 19, 2018
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE August 16, 2018
Estimated Primary Completion Date July 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
Percentage of subjects with one or more culture-verified acute VVC episodes during the maintenance phase [ Time Frame: 48 weeks ]
An acute VVC episode during the maintenance phase (considered a recurrent episode) is defined as a positive culture for Candida species and a clinical signs and symptoms score of ≥3.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03562156 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
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 Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VT-1161 Oral Capsules in the Treatment of 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 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 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 VT-1161 150 mg or a placebo (according to a random assignment), and then a 36-week follow-up period.

This study is identical to VMT-VT-1161-CL-012.

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
    VT-1161 150mg capsule
  • Drug: Placebo
    matching placebo capsule
Study Arms  ICMJE
  • Experimental: VT-1161 150mg capsule
    Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks
    Intervention: Drug: VT-1161
  • Placebo Comparator: Control capsule
    Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks
    Intervention: 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 20, 2020
Estimated Primary Completion Date July 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • 3 or more episodes of acute VVC in the past 12 months
  • Positive KOH or Gram stain
  • 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
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: Stephen Brand, PhD 919-467-8539 info@mycovia.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03562156
Other Study ID Numbers  ICMJE VMT-VT-1161-CL-011
Has Data Monitoring Committee Not Provided
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 April 2019

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