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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. 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: NCT03840616
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : April 16, 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 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.


Condition or disease Intervention/treatment Phase
Recurrent Vulvovaginal Candidiasis Drug: VT-1161 150 mg capsule Drug: Fluconazole 150 mg Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections
Drug Information available for: Fluconazole

Arm Intervention/treatment
Experimental: VT-1161 150 mg capsule 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.

Active Comparator: Fluconazole 150 mg 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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.



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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

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

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): NCT03840616


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: NCT03840616     History of Changes
Other Study ID Numbers: VMT-VT-1161-CL-017
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: April 16, 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
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors