Vulvovaginal Candidiasis
Conditions
Keywords
vulvovaginal candidiasis, candida, VVC, rVVC, Ibrexafungerp, yeast vaginitis
Brief summary
This study will treat subjects with complicated VVC who have failed prior fluconazole therapy with Ibrexafungerp for 1, 3 or 7 days of treatment.
Detailed description
This study will treat subjects with complicated VVC who have failed prior fluconazole therapy with Ibrexafungerp for 1, 3 or 7 days of treatment. Approximately 150 eligible subjects will be enrolled. Subjects will be randomized to receive oral ibrexafungerp 300 mg administered twice a day (BID) for either one, three, or seven consecutive days, stratified by group based on Candida species and presence or absence of underlying medical conditions. The primary endpoint for this study is the percentage of subjects with a clinical cure at the Test of Cure Visit. Test of Cure is defined as a score of zero on the Vulvovaginal Signs and Symptoms Scale and not requiring additional antifungal treatment.
Interventions
DRUGIbrexafungerp
Each day dosing will consist of two 150mg tablets taken BID.
Sponsors
Scynexis, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, 3 group, stratified
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is a post menarchal female ≥18 years of age at the time of signing the ICF. 2. Subject has a diagnosis of symptomatic VVC that meets the following criteria at the Screening visit: 1. Minimum composite vulvovaginal signs and symptoms score of ≥4 with at least 2 signs or symptoms having a score of 2 (moderate) or greater on the VSS scale at baseline. 2. Positive microscopic examination with 10% KOH in a vaginal sample collected at Screening revealing yeast forms (hyphae/pseudohyphae) or budding yeasts 3. Normal vaginal pH (≤ 4.5). 4. Has no other vaginal co-infections based on wet mount microscopic examination (and/or DNA probe). 3. Subject should also have: 1. A VVC with persistent symptoms despite fluconazole therapy (last dose of fluconazole must have been administered at least 7 days prior, but no longer than 28 days prior to screening. OR 2. A recurrent vulvovaginal candidiasis (RVVC) episode with breakthrough symptoms while receiving maintenance antifungal therapy. OR 3. A VVC episode caused by a non-albicans candida species known to have either intrinsic resistance to fluconazole e.g. C.krusei or suspected resistance to fluconazole, e.g. C.glabrata, C. auris but likely without MIC data in hand. OR 4. A VVC episode caused by Candida species with documented resistance to fluconazole based on MIC determination. OR 5. A known history of azole allergy or intolerance. 4. Subject is able to take oral tablets. 5. Subject is not pregnant or lactating and plans not to become pregnant. Women of childbearing potential \< 1 year post-menopausal must agree to and comply with using one barrier method (male condom, female condom, and diaphragm) plus one other highly effective method of birth control, or sexual abstinence, from the time of consent through 10 days after the completion of study therapy. Subjects must refrain from using any topical vaginal contraceptives as these may have an impact on the signs and symptoms of VVC. Note: Women of childbearing potential must have a negative urine pregnancy test prior to enrollment (performed by the site's local laboratory). 6. Subject is able to understand and sign a written ICF, which must be obtained prior to treatment and any study-related procedures. 7. Subject is able to understand and sign a consent or authorization form, which shall permit the use, disclosure and transfer of the subject's personal health information (e.g., in the US Health Information Portability and Accountability Act Authorization form). 8. Subject is able to understand and follow all study-related procedures including study drug administration.
Exclusion criteria
1. Subject has any vaginal condition other than VVC that may interfere with the diagnosis or evaluation of response to therapy, such as concurrent causes of vulvovaginitis and/or cervicitis including bacterial vaginosis, Trichomonas, Herpes virus, Neisseria gonorrhoeae, Chlamydia, symptomatic human papillomavirus infection, or other mixed infections. 2. Subject received systemic and/or topical vaginal antifungal treatment, including prescription or over-the-counter products, within 7 days prior to the Screening visit. Note: The screening visit may be rescheduled if required. 3. Subject is receiving or anticipates requiring treatment with the prohibited medications within the specified timeframes per Appendix I. 4. Subject has active menstruation at the Screening visit. Note: The Screening visit may be rescheduled if required. 5. Subject has a history of or an active cervical/vaginal cancer. 6. Subject has a known hypersensitivity to any of the components of the formulation. 7. Subject has participated in any other investigational study within at least 30 days (or 5.5 half- lives of the investigational product) before signing the ICF. 8. Subject has received prior treatment with ibrexafungerp. 9. Subject has any other condition or laboratory abnormality (such as severe hepatic impairment) that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study. 10. Subject is unlikely to comply with protocol requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure | 14 days post-Baseline - Test-Of-Cure (TOC) | Percentage of participants with complete resolution of signs and symptoms (total VSS score of 0) with no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment. | Percentage of participants with at least 50% reduction from baseline in the total composite VSS score and no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse. |
| Mycological Response | 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment. | Percentage of participants with negative culture growth for candida or participant was asymptomatic and a culture was not done |
| Clinical Cure and Mycological Response | 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment | The number (percentage) of participants with Clinical Cure and Mycological Response at TOC and FU Visits |
| Clinical Improvement | 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment | Percentage of participants with a Total Composite Score of ≤1 on the VSS Scale and a Total Composite Score of ≤2 on the VSS scale. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse. |
| Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | From Baseline to 14 days post-Baseline (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-EOT and 60 days post-EOT | The mean change in total composite vulvovaginal signs and symptom (VSS) score from Baseline to TOC and Follow-up Visits. The VSS score ranges from 0 (no signs and symptoms) to a maximum of 18, with higher scores being worse. |
| Clinical Improvement - 2 | 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment, 30 days post-Baseline, 30 days post-End of Treatment and 60 days post- End of Treatment | Percentage of subjects with a Total Composite Score of 2 on the VSS Scale or a composite score of 1 on the VSS scale. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse. |
| Clinical Cure at Follow-up | 14 days post EOT, 30 days post-Baseline, 30 days post-EOT and 60 days post-EOT | The number (percentage) of participants with a total composite score of 0 on the VSS scale and no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID. | 27 |
| Group B (3 Day Dosing) Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID. | 62 |
| Group B (7 Day Dosing) Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID. | 61 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 | 2 |
| Overall Study | Physician Decision | 1 | 3 | 3 |
| Overall Study | Reason not defined | 3 | 5 | 6 |
| Overall Study | Withdrawal by Subject | 4 | 11 | 7 |
Baseline characteristics
| Characteristic | Group A | Group B (3 Day Dosing) | Group B (7 Day Dosing) | Total |
|---|---|---|---|---|
| Age, Continuous | 40.2 years STANDARD_DEVIATION 14.8 | 39.6 years STANDARD_DEVIATION 13.5 | 39.3 years STANDARD_DEVIATION 11.43 | 39.6 years STANDARD_DEVIATION 12.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 14 Participants | 18 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 48 Participants | 43 Participants | 112 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 15 Participants | 14 Participants | 40 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 13 Participants | 42 Participants | 45 Participants | 100 Participants |
| Sex: Female, Male Female | 27 Participants | 62 Participants | 61 Participants | 150 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 62 | 0 / 61 |
| other Total, other adverse events | 12 / 27 | 35 / 62 | 39 / 61 |
| serious Total, serious adverse events | 0 / 27 | 0 / 62 | 0 / 61 |
Outcome results
Primary
Clinical Cure
Percentage of participants with complete resolution of signs and symptoms (total VSS score of 0) with no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Time frame: 14 days post-Baseline - Test-Of-Cure (TOC)
Population: Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at screening
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Clinical Cure | 7 Participants |
| Group B (3 Day Dosing) | Clinical Cure | 10 Participants |
| Group B (7 Day Dosing) | Clinical Cure | 23 Participants |
Secondary
Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline
The mean change in total composite vulvovaginal signs and symptom (VSS) score from Baseline to TOC and Follow-up Visits. The VSS score ranges from 0 (no signs and symptoms) to a maximum of 18, with higher scores being worse.
Time frame: From Baseline to 14 days post-Baseline (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-EOT and 60 days post-EOT
Population: Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at Screening
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group A | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | 30 days post-EOT | -10.7 Score on a scale |
| Group A | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | 30 days post-Baseline | -7.0 Score on a scale |
| Group A | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | TOC | -7.2 Score on a scale |
| Group A | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | 14 days post-EOT | -10.0 Score on a scale |
| Group A | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | 60 days post-EOT | -8.3 Score on a scale |
| Group B (3 Day Dosing) | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | 30 days post-Baseline | -7.1 Score on a scale |
| Group B (3 Day Dosing) | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | TOC | -6.3 Score on a scale |
| Group B (3 Day Dosing) | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | 14 days post-EOT | -6.7 Score on a scale |
| Group B (3 Day Dosing) | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | 30 days post-EOT | -7.6 Score on a scale |
| Group B (3 Day Dosing) | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | 60 days post-EOT | -8.2 Score on a scale |
| Group B (7 Day Dosing) | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | 60 days post-EOT | -8.5 Score on a scale |
| Group B (7 Day Dosing) | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | 30 days post-EOT | -8.0 Score on a scale |
| Group B (7 Day Dosing) | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | TOC | -8.1 Score on a scale |
| Group B (7 Day Dosing) | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | 30 days post-Baseline | -8.3 Score on a scale |
| Group B (7 Day Dosing) | Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline | 14 days post-EOT | -7.8 Score on a scale |
Secondary
Clinical Cure and Mycological Response
The number (percentage) of participants with Clinical Cure and Mycological Response at TOC and FU Visits
Time frame: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment
Population: Modified Intent-to-Treat (mITT) - all treated participants who have a positive culture for candida species at Screening
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Clinical Cure and Mycological Response | 30 days post-EOT | 3 Participants |
| Group A | Clinical Cure and Mycological Response | 14 days post-EOT | 3 Participants |
| Group A | Clinical Cure and Mycological Response | 60 days post-EOT | 8 Participants |
| Group A | Clinical Cure and Mycological Response | TOC | 5 Participants |
| Group A | Clinical Cure and Mycological Response | 30 days post-Baseline | 7 Participants |
| Group B (3 Day Dosing) | Clinical Cure and Mycological Response | TOC | 7 Participants |
| Group B (3 Day Dosing) | Clinical Cure and Mycological Response | 30 days post-EOT | 8 Participants |
| Group B (3 Day Dosing) | Clinical Cure and Mycological Response | 30 days post-Baseline | 15 Participants |
| Group B (3 Day Dosing) | Clinical Cure and Mycological Response | 60 days post-EOT | 17 Participants |
| Group B (3 Day Dosing) | Clinical Cure and Mycological Response | 14 days post-EOT | 5 Participants |
| Group B (7 Day Dosing) | Clinical Cure and Mycological Response | 60 days post-EOT | 20 Participants |
| Group B (7 Day Dosing) | Clinical Cure and Mycological Response | 14 days post-EOT | 13 Participants |
| Group B (7 Day Dosing) | Clinical Cure and Mycological Response | 30 days post-Baseline | 20 Participants |
| Group B (7 Day Dosing) | Clinical Cure and Mycological Response | 30 days post-EOT | 17 Participants |
| Group B (7 Day Dosing) | Clinical Cure and Mycological Response | TOC | 16 Participants |
Secondary
Clinical Cure at Follow-up
The number (percentage) of participants with a total composite score of 0 on the VSS scale and no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Time frame: 14 days post EOT, 30 days post-Baseline, 30 days post-EOT and 60 days post-EOT
Population: Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at Screening
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Clinical Cure at Follow-up | 14 days post-EOT | 3 Participants |
| Group A | Clinical Cure at Follow-up | 30 days post-Baseline | 7 Participants |
| Group A | Clinical Cure at Follow-up | 30 days post-EOT | 3 Participants |
| Group A | Clinical Cure at Follow-up | 60 days post-EOT | 8 Participants |
| Group B (3 Day Dosing) | Clinical Cure at Follow-up | 60 days post-EOT | 17 Participants |
| Group B (3 Day Dosing) | Clinical Cure at Follow-up | 14 days post-EOT | 6 Participants |
| Group B (3 Day Dosing) | Clinical Cure at Follow-up | 30 days post-EOT | 8 Participants |
| Group B (3 Day Dosing) | Clinical Cure at Follow-up | 30 days post-Baseline | 16 Participants |
| Group B (7 Day Dosing) | Clinical Cure at Follow-up | 60 days post-EOT | 20 Participants |
| Group B (7 Day Dosing) | Clinical Cure at Follow-up | 30 days post-Baseline | 21 Participants |
| Group B (7 Day Dosing) | Clinical Cure at Follow-up | 30 days post-EOT | 17 Participants |
| Group B (7 Day Dosing) | Clinical Cure at Follow-up | 14 days post-EOT | 17 Participants |
Secondary
Clinical Improvement
Percentage of participants with a Total Composite Score of ≤1 on the VSS Scale and a Total Composite Score of ≤2 on the VSS scale. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Time frame: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment
Population: Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at screening
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Clinical Improvement | VSS Score ≤1, (30 days post-Baseline) | 10 Participants |
| Group A | Clinical Improvement | VSS Score ≤2, (30 days post-Baseline) | 10 Participants |
| Group A | Clinical Improvement | VSS Score ≤2, (TOC) | 11 Participants |
| Group A | Clinical Improvement | VSS Score ≤1, (30 days post-EOT | 3 Participants |
| Group A | Clinical Improvement | VSS Score ≤1, (14 days post-EOT) | 3 Participants |
| Group A | Clinical Improvement | VSS Score ≤2, (60 days post-EOT) | 8 Participants |
| Group A | Clinical Improvement | VSS Score ≤1, (60 days post-EOT) | 8 Participants |
| Group A | Clinical Improvement | VSS Score ≤2, (30 days post-EOT) | 3 Participants |
| Group A | Clinical Improvement | VSS Score ≤2, (14 days post-EOT) | 3 Participants |
| Group A | Clinical Improvement | VSS Score ≤1, (TOC) | 10 Participants |
| Group B (3 Day Dosing) | Clinical Improvement | VSS Score ≤2, (14 days post-EOT) | 10 Participants |
| Group B (3 Day Dosing) | Clinical Improvement | VSS Score ≤2, (30 days post-Baseline) | 20 Participants |
| Group B (3 Day Dosing) | Clinical Improvement | VSS Score ≤2, (30 days post-EOT) | 8 Participants |
| Group B (3 Day Dosing) | Clinical Improvement | VSS Score ≤1, (14 days post-EOT) | 8 Participants |
| Group B (3 Day Dosing) | Clinical Improvement | VSS Score ≤2, (60 days post-EOT) | 18 Participants |
| Group B (3 Day Dosing) | Clinical Improvement | VSS Score ≤1, (30 days post-Baseline) | 18 Participants |
| Group B (3 Day Dosing) | Clinical Improvement | VSS Score ≤1, (30 days post-EOT | 8 Participants |
| Group B (3 Day Dosing) | Clinical Improvement | VSS Score ≤2, (TOC) | 23 Participants |
| Group B (3 Day Dosing) | Clinical Improvement | VSS Score ≤1, (60 days post-EOT) | 18 Participants |
| Group B (3 Day Dosing) | Clinical Improvement | VSS Score ≤1, (TOC) | 20 Participants |
| Group B (7 Day Dosing) | Clinical Improvement | VSS Score ≤2, (60 days post-EOT) | 24 Participants |
| Group B (7 Day Dosing) | Clinical Improvement | VSS Score ≤1, (TOC) | 29 Participants |
| Group B (7 Day Dosing) | Clinical Improvement | VSS Score ≤2, (TOC) | 33 Participants |
| Group B (7 Day Dosing) | Clinical Improvement | VSS Score ≤1, (14 days post-EOT) | 22 Participants |
| Group B (7 Day Dosing) | Clinical Improvement | VSS Score ≤1, (30 days post-Baseline) | 24 Participants |
| Group B (7 Day Dosing) | Clinical Improvement | VSS Score ≤1, (30 days post-EOT | 20 Participants |
| Group B (7 Day Dosing) | Clinical Improvement | VSS Score ≤2, (14 days post-EOT) | 26 Participants |
| Group B (7 Day Dosing) | Clinical Improvement | VSS Score ≤2, (30 days post-Baseline) | 26 Participants |
| Group B (7 Day Dosing) | Clinical Improvement | VSS Score ≤2, (30 days post-EOT) | 20 Participants |
| Group B (7 Day Dosing) | Clinical Improvement | VSS Score ≤1, (60 days post-EOT) | 21 Participants |
Secondary
Clinical Improvement - 2
Percentage of subjects with a Total Composite Score of 2 on the VSS Scale or a composite score of 1 on the VSS scale. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Time frame: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment, 30 days post-Baseline, 30 days post-End of Treatment and 60 days post- End of Treatment
Population: Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at Screening
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Clinical Improvement - 2 | VSS Score of 2 at 14 days post-EOT | 0 Participants |
| Group A | Clinical Improvement - 2 | VSS Score of 1 at 30 days post-Baseline | 3 Participants |
| Group A | Clinical Improvement - 2 | VSS Score of 2 at 30 days post-Baseline | 0 Participants |
| Group A | Clinical Improvement - 2 | VSS Score of 2 at 30 days post-EOT | 0 Participants |
| Group A | Clinical Improvement - 2 | VSS Score of 1 at TOC | 3 Participants |
| Group A | Clinical Improvement - 2 | VSS Score of 2 at 60 days post-EOT | 0 Participants |
| Group A | Clinical Improvement - 2 | VSS Score of 1 at 30 days post-EOT | 0 Participants |
| Group A | Clinical Improvement - 2 | VSS Score of 1 at 14 days post-EOT | 0 Participants |
| Group A | Clinical Improvement - 2 | VSS Score of 1 at 60 days post-EOT | 0 Participants |
| Group A | Clinical Improvement - 2 | VSS Score of 2 at TOC | 1 Participants |
| Group B (3 Day Dosing) | Clinical Improvement - 2 | VSS Score of 2 at 14 days post-EOT | 2 Participants |
| Group B (3 Day Dosing) | Clinical Improvement - 2 | VSS Score of 1 at 30 days post-EOT | 0 Participants |
| Group B (3 Day Dosing) | Clinical Improvement - 2 | VSS Score of 2 at TOC | 3 Participants |
| Group B (3 Day Dosing) | Clinical Improvement - 2 | VSS Score of 1 at 30 days post-Baseline | 2 Participants |
| Group B (3 Day Dosing) | Clinical Improvement - 2 | VSS Score of 1 at TOC | 10 Participants |
| Group B (3 Day Dosing) | Clinical Improvement - 2 | VSS Score of 2 at 30 days post-EOT | 0 Participants |
| Group B (3 Day Dosing) | Clinical Improvement - 2 | VSS Score of 1 at 60 days post-EOT | 1 Participants |
| Group B (3 Day Dosing) | Clinical Improvement - 2 | VSS Score of 1 at 14 days post-EOT | 2 Participants |
| Group B (3 Day Dosing) | Clinical Improvement - 2 | VSS Score of 2 at 60 days post-EOT | 0 Participants |
| Group B (3 Day Dosing) | Clinical Improvement - 2 | VSS Score of 2 at 30 days post-Baseline | 2 Participants |
| Group B (7 Day Dosing) | Clinical Improvement - 2 | VSS Score of 2 at 60 days post-EOT | 3 Participants |
| Group B (7 Day Dosing) | Clinical Improvement - 2 | VSS Score of 1 at TOC | 6 Participants |
| Group B (7 Day Dosing) | Clinical Improvement - 2 | VSS Score of 1 at 14 days post-EOT | 5 Participants |
| Group B (7 Day Dosing) | Clinical Improvement - 2 | VSS Score of 1 at 30 days post-Baseline | 3 Participants |
| Group B (7 Day Dosing) | Clinical Improvement - 2 | VSS Score of 1 at 30 days post-EOT | 3 Participants |
| Group B (7 Day Dosing) | Clinical Improvement - 2 | VSS Score of 1 at 60 days post-EOT | 1 Participants |
| Group B (7 Day Dosing) | Clinical Improvement - 2 | VSS Score of 2 at TOC | 4 Participants |
| Group B (7 Day Dosing) | Clinical Improvement - 2 | VSS Score of 2 at 14 days post-EOT | 4 Participants |
| Group B (7 Day Dosing) | Clinical Improvement - 2 | VSS Score of 2 at 30 days post-Baseline | 2 Participants |
| Group B (7 Day Dosing) | Clinical Improvement - 2 | VSS Score of 2 at 30 days post-EOT | 0 Participants |
Secondary
Clinical Success
Percentage of participants with at least 50% reduction from baseline in the total composite VSS score and no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Time frame: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment.
Population: Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at screening
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Clinical Success | TOC | 11 Participants |
| Group A | Clinical Success | 30 days post-EOT | 3 Participants |
| Group A | Clinical Success | 30 days post-Baseline | 10 Participants |
| Group A | Clinical Success | 60 days post-EOT | 8 Participants |
| Group A | Clinical Success | 14 days post-EOT | 3 Participants |
| Group B (3 Day Dosing) | Clinical Success | 60 days post-EOT | 18 Participants |
| Group B (3 Day Dosing) | Clinical Success | TOC | 31 Participants |
| Group B (3 Day Dosing) | Clinical Success | 14 days post-EOT | 12 Participants |
| Group B (3 Day Dosing) | Clinical Success | 30 days post-Baseline | 23 Participants |
| Group B (3 Day Dosing) | Clinical Success | 30 days post-EOT | 9 Participants |
| Group B (7 Day Dosing) | Clinical Success | 14 days post-EOT | 28 Participants |
| Group B (7 Day Dosing) | Clinical Success | 60 days post-EOT | 25 Participants |
| Group B (7 Day Dosing) | Clinical Success | 30 days post-EOT | 22 Participants |
| Group B (7 Day Dosing) | Clinical Success | TOC | 39 Participants |
| Group B (7 Day Dosing) | Clinical Success | 30 days post-Baseline | 27 Participants |
Secondary
Mycological Response
Percentage of participants with negative culture growth for candida or participant was asymptomatic and a culture was not done
Time frame: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment.
Population: Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at Screening
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Mycological Response | 60 days post-EOT | 9 Participants |
| Group A | Mycological Response | 30 days post-Baseline | 7 Participants |
| Group A | Mycological Response | 14 days post-EOT | 3 Participants |
| Group A | Mycological Response | TOC | 9 Participants |
| Group A | Mycological Response | 30 days post-EOT | 3 Participants |
| Group B (3 Day Dosing) | Mycological Response | TOC | 23 Participants |
| Group B (3 Day Dosing) | Mycological Response | 60 days post-EOT | 19 Participants |
| Group B (3 Day Dosing) | Mycological Response | 30 days post-EOT | 9 Participants |
| Group B (3 Day Dosing) | Mycological Response | 30 days post-Baseline | 18 Participants |
| Group B (3 Day Dosing) | Mycological Response | 14 days post-EOT | 8 Participants |
| Group B (7 Day Dosing) | Mycological Response | 60 days post-EOT | 24 Participants |
| Group B (7 Day Dosing) | Mycological Response | 14 days post-EOT | 21 Participants |
| Group B (7 Day Dosing) | Mycological Response | 30 days post-Baseline | 25 Participants |
| Group B (7 Day Dosing) | Mycological Response | 30 days post-EOT | 20 Participants |
| Group B (7 Day Dosing) | Mycological Response | TOC | 31 Participants |