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A Study of Oral Oteseconazole (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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03561701
Recruitment Status : Completed
First Posted : June 19, 2018
Results First Posted : December 20, 2021
Last Update Posted : December 20, 2021
Sponsor:
Information provided by (Responsible Party):
Mycovia Pharmaceuticals Inc.

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 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.


Condition or disease Intervention/treatment Phase
Recurrent Vulvovaginal Candidiasis Drug: Oteseconazole (VT-1161) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 425 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 23, 2018
Actual Primary Completion Date : October 13, 2020
Actual Study Completion Date : August 3, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

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




Primary Outcome Measures :
  1. 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 (post-randomization 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)




Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561701


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

Documents provided by Mycovia Pharmaceuticals Inc.:
Study Protocol  [PDF] October 1, 2019
Statistical Analysis Plan  [PDF] July 31, 2020

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Responsible Party: Mycovia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03561701    
Other Study ID Numbers: VMT-VT-1161-CL-012
First Posted: June 19, 2018    Key Record Dates
Results First Posted: December 20, 2021
Last Update Posted: December 20, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Vulvovaginal
Recurrence
Disease Attributes
Pathologic Processes
Mycoses
Bacterial Infections and Mycoses
Infections
Vulvovaginitis
Vaginitis
Vaginal Diseases
Vulvitis
Vulvar Diseases