Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02733432 | RADIANT: CD101 vs Standard of Care in Subjects With Acute Vaginal Yeast Infections | PHASE2 | COMPLETED | 126 | — | — | Jun 8, 2016 | Dec 23, 2016 | Aug 31, 2020 | 24 | United States |
adverse events, clinical chemistry and hematology, pelvic exams
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | CD101 Vaginal Gel (3%) topically self-administered intravaginally as a single dose on days 1 and 2 and for symptomatic relief CD101 External Gel (1%)topically self-applied to external vulva up to twice per day over 72 hours. |
| Cohort 2 | EXPERIMENTAL | CD101 Vaginal Ointment (6%) topically self-administered intravaginally as a single dose on day 1 and for symptomatic relief CD101 External Ointment (1%) topically self-applied to external vulva up to twice per day over 72 hours. |
| Cohort 3 | ACTIVE_COMPARATOR | Oral fluconazole (150mg) administered on day 1. |
| Name | Type | Description |
|---|---|---|
| CD101 Vaginal Gel (3%) | DRUG | CD101 Vaginal Gel (3%) intravaginally applied topical gel on Days 1 and 2 |
| CD101 External gel (1%) | DRUG | CD101 external gel (1%) applied topically twice daily over 72 hours as needed |
| CD101 Vaginal Ointment (6%) | DRUG | CD101 vaginal ointment (6%) intravaginally applied topical ointment on Day 1 |
| CD101 External ointment (1%) | DRUG | CD101 external ointment (1%) applied topically twice daily over 72 hours as needed |
| Fluconazole | DRUG | oral fluconazole (150mg) on Day 1 |
Inclusion Criteria: * moderate to severe acute vulvovaginal candidiasis (severity score \>7) * positive potassium hydroxide wet preparation for pseudohyphae or budding yeast or positive Becton Dickinson Affirm test or positive vaginal culture for Candida species * vaginal pH \<4.5 for subjects with...