Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections (ultraVIOLET)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03840616 |
|
Recruitment Status :
Completed
First Posted : February 15, 2019
Results First Posted : February 4, 2022
Last Update Posted : February 4, 2022
|
Sponsor:
Mycovia Pharmaceuticals Inc.
Information provided by (Responsible Party):
Mycovia Pharmaceuticals Inc.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
| Condition |
Recurrent Vulvovaginal Candidiasis |
| Interventions |
Drug: Oteseconazole (VT-1161) 150mg capsule Drug: Fluconazole 150mg capsule Drug: Placebo |
| Enrollment | 219 |
Participant Flow
| Recruitment Details | After providing consent, 251 subjects were screened and, of those, a total of 219 subjects were randomly assigned to the oteseconazole or fluconazole/placebo group for a 2-week induction phase. During the induction phase, subjects received either oteseconazole or fluconazole. Subjects whose presenting acute VVC episode resolved during the induction phase (a total of 185 subjects) entered a 48-week maintenance phase comprised of an 11-week treatment period and a 37-week follow-up period. |
| Pre-assignment Details | Of the 251 subjects screened, 32 did not meet eligibility requirements and were not enrolled (i.e., not assigned to a treatment arm for the 2-week induction phase). |
| Arm/Group Title | Oteseconazole (VT-1161) | Fluconazole / Placebo |
|---|---|---|
 Arm/Group Description |
600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14. | 150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14. |
| Period Title: 2-Week Induction Phase | ||
| Started | 147 | 72 |
| Completed | 123 | 62 |
| Not Completed | 24 | 10 |
| Period Title: 48-Week Maintenance Phase | ||
| Started | 123 | 62 |
| Completed | 112 | 55 |
| Not Completed | 11 | 7 |
Baseline Characteristics
| Arm/Group Title | Oteseconazole (VT-1161) | Fluconazole / Placebo | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14. | 150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 147 | 72 | 219 | |
|
Baseline Analysis Population Description |
[Not Specified]
|
|||
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 147 participants | 72 participants | 219 participants | |
| 34 (10.7) | 36 (11.7) | 35 (11.0) | ||
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 147 participants | 72 participants | 219 participants | |
| Female |
147 100.0%
|
72 100.0%
|
219 100.0%
|
|
| Male |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 147 participants | 72 participants | 219 participants | |
| American Indian or Alaska Native |
1 0.7%
|
1 1.4%
|
2 0.9%
|
|
| Asian |
3 2.0%
|
0 0.0%
|
3 1.4%
|
|
| Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
| Black or African American |
47 32.0%
|
27 37.5%
|
74 33.8%
|
|
| White |
88 59.9%
|
42 58.3%
|
130 59.4%
|
|
| More than one race |
7 4.8%
|
2 2.8%
|
9 4.1%
|
|
| Unknown or Not Reported |
1 0.7%
|
0 0.0%
|
1 0.5%
|
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||
| United States | Number Analyzed | 147 participants | 72 participants | 219 participants |
| 147 | 72 | 219 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Neither institution nor investigator can disclose information pertaining to study until sponsor issues multi-center publication. If multi-center publication is not issued within 18 months of study completion and database lock at all sites, sponsor has 30 days from receipt to review institution's and/or investigator's communication and can require removal of confidential information other than study data and/or delay release of institution's and/or investigator's communication for 60 days.
Results Point of Contact
| Name/Title: | Clinical Trial Administration |
| Organization: | Mycovia Pharmaceuticals Inc |
| Phone: | 919-467-8539 |
| EMail: | adminops@mycovia.com |
| Responsible Party: | Mycovia Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT03840616 |
| Other Study ID Numbers: |
VMT-VT-1161-CL-017 |
| First Submitted: | February 11, 2019 |
| First Posted: | February 15, 2019 |
| Results First Submitted: | November 29, 2021 |
| Results First Posted: | February 4, 2022 |
| Last Update Posted: | February 4, 2022 |