Trial · NCT02267382
A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
NCT02267382, Phase 2, Completed, Viamet; results first posted 2019-10-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection). Trials, record NCT02267382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02267382
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
- NCT number
- NCT02267382
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 254 participants, actual
- Lead sponsor
- Viamet
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Interventions
- VT-1161, Placebo
- First posted
- 2014-10-17
- Last updated
- 2019-10-15
- Results first posted
- 2019-10-04
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. | 48 Weeks | A culture-verified acute VVC episode was defined as a positive fungal culture for Candida species associated with 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 higher scores 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
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. | 48 Weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. | VT-1161 Low-dose 3-month | 2 | Participants | ||
| The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. | VT-1161 Low-dose 6-month | 3 | Participants | ||
| The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. | VT-1161 High-dose 3-month | 0 | Participants | ||
| The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. | VT-1161 High-dose 24-week | 2 | Participants | ||
| The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. | Placebo | 24 | Participants |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | VT-1161 Low-dose 3-month | 42 | |
| Overall Study | STARTED | VT-1161 Low-dose 6-month | 43 | |
| Overall Study | STARTED | VT-1161 High-dose 3-month | 43 | |
| Overall Study | STARTED | VT-1161 High-dose 24-week | 41 | |
| Overall Study | STARTED | Placebo | 46 | |
| Overall Study | COMPLETED | VT-1161 Low-dose 3-month | 35 | |
| Overall Study | COMPLETED | VT-1161 Low-dose 6-month | 33 | |
| Overall Study | COMPLETED | VT-1161 High-dose 3-month | 34 | |
| Overall Study | COMPLETED | VT-1161 High-dose 24-week | 35 | |
| Overall Study | COMPLETED | Placebo | 39 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events900
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 | Ear pain | Ear and labyrinth disorders | VT-1161 Low-dose 3-month | 0 | 41 | |
| other | Ear pain | Ear and labyrinth disorders | VT-1161 Low-dose 6-month | 0 | 42 | |
| other | Ear pain | Ear and labyrinth disorders | VT-1161 High-dose 3-month | 0 | 42 | |
| other | Ear pain | Ear and labyrinth disorders | VT-1161 High-dose 24-week | 0 | 41 | |
| other | Ear pain | Ear and labyrinth disorders | Placebo | 1 | 45 | |
| other | Conjunctivitis | Eye disorders | VT-1161 Low-dose 3-month | 0 | 41 | |
| other | Conjunctivitis | Eye disorders | VT-1161 Low-dose 6-month | 1 | 42 | |
| other | Conjunctivitis | Eye disorders | VT-1161 High-dose 3-month | 0 | 42 | |
| other | Conjunctivitis | Eye disorders | VT-1161 High-dose 24-week | 0 | 41 | |
| other | Conjunctivitis | Eye disorders | Placebo | 0 | 45 |
1 to 10 of 900Source ClinicalTrials.gov
See all 900 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | VT-1161 Low-dose 3-month | ||
| Total, all-cause mortality | VT-1161 Low-dose 6-month | ||
| Total, all-cause mortality | VT-1161 High-dose 3-month | ||
| Total, all-cause mortality | VT-1161 High-dose 24-week | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | VT-1161 Low-dose 3-month | 26 | 41 |
| Total, other adverse events | VT-1161 Low-dose 6-month | 31 | 42 |
| Total, other adverse events | VT-1161 High-dose 3-month | 30 | 42 |
| Total, other adverse events | VT-1161 High-dose 24-week | 28 | 41 |
| Total, other adverse events | Placebo | 35 | 45 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02267382
GET https://conductscience.org/api/trials/v1/NCT02267382/events?page=2