Trial · NCT03840616

Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections

NCT03840616, Phase 3, Completed, Mycovia Pharmaceuticals Inc.; results first posted 2022-02-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections. Trials, record NCT03840616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03840616

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections
NCT number: NCT03840616
Status: Completed
Phases: Phase 3
Enrollment: 219 participants, actual
Lead sponsor: Mycovia Pharmaceuticals Inc.
Conditions: Recurrent Vulvovaginal Candidiasis
Interventions: Oteseconazole (VT-1161) 150mg capsule, Fluconazole 150mg capsule, Placebo
First posted: 2019-02-15
Last updated: 2022-02-04
Results first posted: 2022-02-04

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	48 Weeks	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, which includes subjects who failed to clear their initial acute VVC episode during the induction phase. 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

Outcomes1

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	48 Weeks	Analysis was performed on the ITT population which includes subjects who failed to clear their initial acute VVC episode during the induction phase. The ITT population was defined as all randomized subjects. Missing values were imputed with multiple imputation using the following auxiliary information: treatment, baseline body mass index, baseline age, ethnicity, and visit. The 'percentage of participants' measure represents an average of 10 individual tests using multiple imputation.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group2

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)		5.1		percentage of participants
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	Fluconazole / Placebo		42.2		percentage of participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
2-Week Induction Phase	STARTED	Oteseconazole (VT-1161)	147
2-Week Induction Phase	STARTED	Fluconazole / Placebo	72
2-Week Induction Phase	COMPLETED	Oteseconazole (VT-1161)	123
2-Week Induction Phase	COMPLETED	Fluconazole / Placebo	62
2-Week Induction Phase	NOT COMPLETED	Oteseconazole (VT-1161)	24
2-Week Induction Phase	NOT COMPLETED	Fluconazole / Placebo	10
48-Week Maintenance Phase	STARTED	Oteseconazole (VT-1161)	123
48-Week Maintenance Phase	STARTED	Fluconazole / Placebo	62
48-Week Maintenance Phase	COMPLETED	Oteseconazole (VT-1161)	112
48-Week Maintenance Phase	COMPLETED	Fluconazole / Placebo	55

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events128

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	Urinary tract infection	Infections and infestations	Oteseconazole (Induction Phase)	1	146	1
other	Urinary tract infection	Infections and infestations	Oteseconazole (Maintenance Phase)	17	123	21
other	Urinary tract infection	Infections and infestations	Fluconazole (Induction Phase)	3	72	3
other	Urinary tract infection	Infections and infestations	Placebo (Maintenance Phase)	11	62	11
other	Bacterial vaginosis	Infections and infestations	Oteseconazole (Induction Phase)	1	146	1
other	Bacterial vaginosis	Infections and infestations	Oteseconazole (Maintenance Phase)	16	123	24
other	Bacterial vaginosis	Infections and infestations	Fluconazole (Induction Phase)	2	72	2
other	Bacterial vaginosis	Infections and infestations	Placebo (Maintenance Phase)	9	62	15
other	Upper respiratory tract infection	Infections and infestations	Oteseconazole (Induction Phase)	0	146	0
other	Upper respiratory tract infection	Infections and infestations	Oteseconazole (Maintenance Phase)	7	123	8

1 to 10 of 128Source ClinicalTrials.gov

See all 128 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oteseconazole (Induction Phase)	0	146
Total, all-cause mortality	Oteseconazole (Maintenance Phase)	1	123
Total, all-cause mortality	Fluconazole (Induction Phase)	0	72
Total, all-cause mortality	Placebo (Maintenance Phase)	0	62
Total, other adverse events	Oteseconazole (Induction Phase)	8	146
Total, other adverse events	Oteseconazole (Maintenance Phase)	35	123
Total, other adverse events	Fluconazole (Induction Phase)	8	72
Total, other adverse events	Placebo (Maintenance Phase)	21	62
Total, serious adverse events	Oteseconazole (Induction Phase)	0	146
Total, serious adverse events	Oteseconazole (Maintenance Phase)	3	123

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36396498	DERIVED

Source PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03840616

GET https://conductscience.org/api/trials/v1/NCT03840616/events?page=2

API reference For AI assistants