Trial · NCT03561701
A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
NCT03561701, Phase 3, Completed, Mycovia Pharmaceuticals Inc.; results first posted 2021-12-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection). Trials, record NCT03561701. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03561701
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
- NCT number
- NCT03561701
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 425 participants, actual
- Lead sponsor
- Mycovia Pharmaceuticals Inc.
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Interventions
- Oteseconazole (VT-1161), Placebo
- First posted
- 2018-06-19
- Last updated
- 2026-02-17
- Results first posted
- 2021-12-20
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population. | Maintenance phase (Baseline through Week 48) | The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and 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 a higher score indicating a worse outcome. 0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population. | Maintenance phase (Baseline through Week 48) | Analysis was performed on the ITT population which included all randomized subjects except the 4 excluded subjects. Missing values were imputed with multiple imputation using the following auxiliary information: region, treatment, baseline body mass index, baseline age, ethnicity, and visit. | percentage of subjects | NUMBER |
| POST_HOC | Extension Study Efficacy Outcome Measure | Extension (Week 49 - Week 96) | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population. | Oteseconazole (VT-1161) | 3.9 | percentage of subjects | ||
| Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population. | Placebo | 39.4 | percentage of subjects | ||
| Extension Study Efficacy Outcome Measure | Oteseconazole (VT-1161) 150mg Capsule | 14.8 | percentage of subjects | ||
| Extension Study Efficacy Outcome Measure | Placebo Capsule | 73.1 | percentage of subjects |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oteseconazole (VT-1161) | 220 | |
| Overall Study | STARTED | Placebo | 110 | |
| Overall Study | COMPLETED | Oteseconazole (VT-1161) | 191 | |
| Overall Study | COMPLETED | Placebo | 91 | |
| Overall Study | NOT COMPLETED | Oteseconazole (VT-1161) | 29 | |
| Overall Study | NOT COMPLETED | Placebo | 19 |
Source ClinicalTrials.gov
Adverse events78
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bacterial vaginosis | Infections and infestations | Oteseconazole (VT-1161) | 14 | 217 | 23 |
| other | Bacterial vaginosis | Infections and infestations | Placebo | 6 | 110 | 7 |
| other | Nasopharyngitis | Infections and infestations | Oteseconazole (VT-1161) | 11 | 217 | 14 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 7 | 110 | 9 |
| other | Urinary tract infection | Infections and infestations | Oteseconazole (VT-1161) | 12 | 217 | 16 |
| other | Urinary tract infection | Infections and infestations | Placebo | 4 | 110 | 6 |
| other | Influenza | Infections and infestations | Oteseconazole (VT-1161) | 6 | 217 | 7 |
| other | Influenza | Infections and infestations | Placebo | 3 | 110 | 3 |
| other | Upper respiratory tract infection | Infections and infestations | Oteseconazole (VT-1161) | 2 | 217 | 2 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 7 | 110 | 7 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oteseconazole (VT-1161) | 0 | 217 |
| Total, all-cause mortality | Placebo | 0 | 110 |
| Total, other adverse events | Oteseconazole (VT-1161) | 112 | 217 |
| Total, other adverse events | Placebo | 63 | 110 |
| Total, serious adverse events | Oteseconazole (VT-1161) | 7 | 217 |
| Total, serious adverse events | Placebo | 5 | 110 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oteseconazole (VT-1161) vs Placebo: deaths from any cause | Trial comparisons |
| Oteseconazole (VT-1161) vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03561701
GET https://conductscience.org/api/trials/v1/NCT03561701/events?page=2