Trial · NCT03987620
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
NCT03987620, Phase 3, Completed, Scynexis, Inc.; results first posted 2021-09-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis. Trials, record NCT03987620. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03987620
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
- NCT number
- NCT03987620
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 455 participants, actual
- Lead sponsor
- Scynexis, Inc.
- Conditions
- Candida Vulvovaginitis
- Interventions
- Ibrexafungerp, Placebo
- First posted
- 2019-06-17
- Last updated
- 2021-09-08
- Results first posted
- 2021-09-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Cure (Complete Resolution of Signs and Symptoms) | Day 8-14 | The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit |
| Secondary | Mycological Eradication (Negative Culture for Growth of Yeast) | Day 8-14 | The percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit |
| Secondary | Clinical Cure and Mycological Eradication (Responder Outcome) | Day 8-14 | The percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit |
| Secondary | Complete Clinical Response at Follow-up | Day 25 | The percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit |
| Secondary | Safety and Tolerability of Ibrexafungerp | Up to 29 Days | Number of subjects with treatment related adverse events |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Cure (Complete Resolution of Signs and Symptoms) | Day 8-14 | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mycological Eradication (Negative Culture for Growth of Yeast) | Day 8-14 | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Cure and Mycological Eradication (Responder Outcome) | Day 8-14 | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Complete Clinical Response at Follow-up | Day 25 | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety and Tolerability of Ibrexafungerp | Up to 29 Days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Cure (Complete Resolution of Signs and Symptoms) | Ibrexafungerp (SCY-078) | Clinical cure | 119 | Participants | |
| Clinical Cure (Complete Resolution of Signs and Symptoms) | Placebo | Clinical cure | 37 | Participants | |
| Clinical Cure (Complete Resolution of Signs and Symptoms) | Ibrexafungerp (SCY-078) | Clinical failure | 69 | Participants | |
| Clinical Cure (Complete Resolution of Signs and Symptoms) | Placebo | Clinical failure | 47 | Participants | |
| Mycological Eradication (Negative Culture for Growth of Yeast) | Ibrexafungerp (SCY-078) | Mycological eradication | 110 | Participants | |
| Mycological Eradication (Negative Culture for Growth of Yeast) | Placebo | Mycological eradication | 25 | Participants | |
| Mycological Eradication (Negative Culture for Growth of Yeast) | Ibrexafungerp (SCY-078) | Mycological persistence | 78 | Participants | |
| Mycological Eradication (Negative Culture for Growth of Yeast) | Placebo | Mycological persistence | 59 | Participants | |
| Clinical Cure and Mycological Eradication (Responder Outcome) | Ibrexafungerp (SCY-078) | Overall success | 82 | Participants | |
| Clinical Cure and Mycological Eradication (Responder Outcome) | Placebo | Overall success | 23 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibrexafungerp (SCY-078) | 303 | |
| Overall Study | STARTED | Placebo | 152 | |
| Overall Study | Withdrawn Before Treatment | Ibrexafungerp (SCY-078) | 5 | |
| Overall Study | Withdrawn Before Treatment | Placebo | 1 | |
| Overall Study | Withdrawn Before TOC | Ibrexafungerp (SCY-078) | 48 | |
| Overall Study | Withdrawn Before TOC | Placebo | 45 | |
| Overall Study | Completed the TOC Visit | Ibrexafungerp (SCY-078) | 250 | |
| Overall Study | Completed the TOC Visit | Placebo | 106 | |
| Overall Study | Withdrawn At or After the TOC Visit | Ibrexafungerp (SCY-078) | 4 | |
| Overall Study | Withdrawn At or After the TOC Visit | Placebo | 4 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events10
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 | Diarrhoea | Gastrointestinal disorders | Ibrexafungerp (SCY-078) | 28 | 298 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 151 | |
| other | Nausea | Gastrointestinal disorders | Ibrexafungerp (SCY-078) | 25 | 298 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 4 | 151 | |
| other | Headache | Nervous system disorders | Ibrexafungerp (SCY-078) | 22 | 298 | |
| other | Headache | Nervous system disorders | Placebo | 11 | 151 | |
| serious | Diabetic ketoacidosis | Metabolism and nutrition disorders | Ibrexafungerp (SCY-078) | 0 | 298 | |
| serious | Diabetic ketoacidosis | Metabolism and nutrition disorders | Placebo | 1 | 151 | |
| serious | Gastrointestinal bacterial infection | Gastrointestinal disorders | Ibrexafungerp (SCY-078) | 1 | 298 | |
| serious | Gastrointestinal bacterial infection | Gastrointestinal disorders | Placebo | 0 | 151 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibrexafungerp (SCY-078) | 0 | 298 |
| Total, all-cause mortality | Placebo | 0 | 151 |
| Total, other adverse events | Ibrexafungerp (SCY-078) | 63 | 298 |
| Total, other adverse events | Placebo | 15 | 151 |
| Total, serious adverse events | Ibrexafungerp (SCY-078) | 1 | 298 |
| Total, serious adverse events | Placebo | 1 | 151 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36255448 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ibrexafungerp (SCY-078) vs Placebo: deaths from any cause | Trial comparisons |
| Ibrexafungerp (SCY-078) 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/NCT03987620
GET https://conductscience.org/api/trials/v1/NCT03987620/results?page=2