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A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)

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ClinicalTrials.gov Identifier: NCT02267382
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Viamet

Brief Summary:
VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161 is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect profile that limits the use of commonly prescribed antifungal agents for the treatment of recurrent yeast infections.

Condition or disease Intervention/treatment Phase
Recurrent Vulvovaginal Candidiasis Drug: VT-1161 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Recurrent Vulvovaginal Candidiasis
Actual Study Start Date : February 10, 2015
Actual Primary Completion Date : November 9, 2016
Actual Study Completion Date : November 9, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: Active Arm 1
Low dose 12-week: Loading doses of VT-1161 150mg once daily for 7 days, then VT-1161 150mg once weekly for 11 weeks, followed by placebo once weekly for 12 weeks
Drug: VT-1161
Experimental: Active Arm 2
Low dose 24-week: Loading doses of VT-1161 150mg once daily for 7 days, then VT-1161 150mg once weekly for 23 weeks
Drug: VT-1161
Experimental: Active Arm 3
High dose 12-week: Loading doses of VT-1161 300mg once daily for 7 days, then VT-1161 300mg once weekly for 11 weeks, followed by placebo once weekly for 12 weeks
Drug: VT-1161
Experimental: Active Arm 4
High dose 24-week: Loading doses of VT-1161 300mg once daily for 7 days, then VT-1161 300mg once weekly for 23 weeks
Drug: VT-1161
Placebo Comparator: Control Arm
Placebo 24 weeks
Drug: Placebo



Primary Outcome Measures :
  1. To evaluate the safety and efficacy of 4 dosing regimens of oral VT-1161 for the prevention of culture-verified acute vulvovaginal candidiasis (VVC) episodes through Week 48 [ Time Frame: 48 Weeks ]
    The primary efficacy outcome measure is the proportion of subjects with one or more culture-verified acute VVC infections during the maintenance Phase through Week 48 of the study. Culture-verified acute VVC is defined as a positive fungal culture for Candida species associated with clinical signs and symptoms of acute VVC.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

Clinical diagnosis of symptomatic acute VVC

3 or more episodes of acute VVC in the past 12 months

Positive KOH

Minimum composite vulvovaginal signs and symptoms score of ≥3 at Screening

Composite vulvovaginal signs and symptoms score of <3 at Baseline

Must be able to swallow tablets

Key Exclusion Criteria:

Evidence of major organ system disease

Presence or a history of another vaginal or vulvar condition(s)

History of cervical cancer

Poorly controlled diabetes mellitus

Pregnant

Recent use of topical or systemic antifungal drugs

Recent use of immunosuppressive or system 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): NCT02267382


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Sponsors and Collaborators
Viamet

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Viamet
ClinicalTrials.gov Identifier: NCT02267382     History of Changes
Other Study ID Numbers: VMT-VT-1161-CL-006
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases