Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections
Public ClinicalTrials.gov record NCT03840616. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 3, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules vs Fluconazole and Placebo in Treatment of Acute Vulvovaginal Candidiasis in Subjects With Recurrent Vulvovaginal Candidiasis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute vulvovaginal candidiasis (VVC) in the past 12 months. Several properties of oteseconazole (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 oteseconazole (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 induction phase for the treatment of the patient's current VVC episode when the patient will take either fluconazole or oteseconazole (VT-1161) according to a random assignment. The second part consists of an 11-week maintenance phase, when the patient will take either oteseconazole (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.
Study identification
- NCT ID
- NCT03840616
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 219 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 13, 2019 (Actual)
- Primary completion
- Dec 2, 2020 (Actual)
- Completion
- Dec 2, 2020 (Actual)
- Last update posted
- Feb 4, 2022
2019 – 2020
United States locations
- U.S. sites
- 33
- U.S. states
- 17
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 34 | Tucson | Arizona | 85712 | — |
| 39 | Encino | California | 91436 | — |
| 25 | Los Angeles | California | 90036 | — |
| 22 | Englewood | Colorado | 80112 | — |
| 49 | Boca Raton | Florida | 33486 | — |
| 14 | Gainesville | Florida | 32607 | — |
| 13 | Leesburg | Florida | 34748 | — |
| 33 | Loxahatchee Groves | Florida | 33470 | — |
| 36 | Miami | Florida | 33155 | — |
| 17 | Savannah | Georgia | 31406 | — |
| 27 | Idaho Falls | Idaho | 83404 | — |
| 10 | Nampa | Idaho | 83687 | — |
| 62 | Chicago | Illinois | 60643 | — |
| 41 | Fort Wayne | Indiana | 46825 | — |
| 30 | Marrero | Louisiana | 70072 | — |
| 50 | Dearborn Heights | Michigan | 48127 | — |
| 29 | Saginaw | Michigan | 48602 | — |
| 55 | Traverse City | Michigan | 49686 | — |
| 32 | Troy | Michigan | 48085 | — |
| 26 | Kansas City | Missouri | 64111 | — |
| 42 | New Brunswick | New Jersey | 08901 | — |
| 47 | Ocean City | New Jersey | 07712 | — |
| 37 | Charlotte | North Carolina | 28207 | — |
| 38 | Fayetteville | North Carolina | 28304 | — |
| 15 | Columbus | Ohio | 43213 | — |
| 18 | Bluffton | South Carolina | 29910 | — |
| 48 | Myrtle Beach | South Carolina | 29572 | — |
| 20 | Bristol | Tennessee | 37620 | — |
| 21 | Murfreesboro | Tennessee | 37130 | — |
| 24 | Austin | Texas | 78705 | — |
| 23 | Fort Worth | Texas | 76104 | — |
| 63 | Katy | Texas | 77450 | — |
| 58 | League City | Texas | 77573 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03840616, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 4, 2022 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03840616 live on ClinicalTrials.gov.