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Trial record 76 of 228 for:    yeast

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
Results First Posted : October 4, 2019
Last Update Posted : October 4, 2019
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: VT-1161 Low-dose 3-month
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
Drug: VT-1161
Experimental: VT-1161 Low-dose 6-month
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks
Drug: VT-1161
Experimental: VT-1161 High-dose 3-month
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
Drug: VT-1161
Experimental: VT-1161 High-dose 24-week
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
Drug: VT-1161
Placebo Comparator: Placebo
2 placebo tablets once daily for 7 days, then once weekly for 23 weeks
Drug: Placebo



Primary Outcome Measures :
  1. The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. [ Time Frame: 48 Weeks ]

    A culture-verified acute VVC episode was defined as a positive fungal culture for Candida species associated with 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 higher scores 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:   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
Results First Posted: October 4, 2019
Last Update Posted: October 4, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases