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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.

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.


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 16, 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 ]
    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.



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
  • 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): NCT03562156


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

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Sponsors and Collaborators
Mycovia Pharmaceuticals Inc.

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Responsible Party: Mycovia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03562156     History of Changes
Other Study ID Numbers: VMT-VT-1161-CL-011
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