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 |
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Recruitment Status :
Recruiting
First Posted : February 15, 2019
Last Update Posted : April 16, 2019
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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 |
| 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 |
| 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. |
- 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.
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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 |
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
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
| Contact: Stephen Brand, PhD | 919-467-8539 | info@mycovia.com |
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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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |