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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: NCT03561701
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : April 17, 2019
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 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-011.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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 VT-1161 Oral Capsules in the Treatment of Subjects With Recurrent Vulvovaginal Candidiasis
Actual Study Start Date : August 23, 2018
Estimated Primary Completion Date : July 20, 2020
Estimated Study Completion Date : July 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: VT-1161 150mg capsule
Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks
Drug: VT-1161
VT-1161 150mg capsule

Placebo Comparator: Control 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 one or more culture-verified acute VVC episodes during the maintenance phase [ Time Frame: 48 weeks ]
    The primary efficacy outcome measure is the proportion of subjects with one 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) is defined as a positive culture for Candida species and a clinical signs and symptoms score of ≥3.



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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
  • 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


Contacts
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Contact: Stephen Brand, PhD 919-467-8539 info@mycovia.com

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

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Responsible Party: Mycovia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03561701     History of Changes
Other Study ID Numbers: VMT-VT-1161-CL-012
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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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
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases