A Study of Oral VT-1161 for the Treatment of Acute Vaginal Candidiasis (Yeast Infection) in Patients With Recurrent Vaginal Candidiasis (ultraVIOLET)
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|ClinicalTrials.gov Identifier: NCT03840616|
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : April 16, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|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).
During Part 2, administered orally once weekly for 11 weeks starting on Day 14.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03840616
|Contact: Stephen Brand, PhDfirstname.lastname@example.org|
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