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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02971007 | Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC) | PHASE2 | COMPLETED | 137 | — | — | Nov 1, 2016 | May 1, 2017 | Nov 2, 2018 | 23 | United States |
Number of patients determined to be a Clinical Cure (resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment); Clinical Failure (incomplete resolution of signs and symptoms of VVC that were present at baseline or new signs and symptoms have developed and require the initiation of non-study antifungal drugs); or Clinical indeterminate (insufficient data are available to determine if the subject is a cure or failure)
| Arm | Type | Description |
|---|---|---|
| CAMB 200 mg | EXPERIMENTAL | 200 mg CAMB (MAT2203) Oral Amphotericin B |
| CAMB 400 mg | EXPERIMENTAL | 400 mg CAMB (MAT2203) Oral Amphotericin B |
| Fluconazole 150 mg | ACTIVE_COMPARATOR | Fluconazole Diflucan |
| Name | Type | Description |
|---|---|---|
| Oral Encochleated Amphotericin B (CAMB) | DRUG | lipid-crystal nano-particle formulation amphotericin B |
| Fluconazole | DRUG | - |
Key Inclusion Criteria: Informed consent Clinical diagnosis of moderate to severe VVC Negative pregnancy test Vaginal pH less than 4.5 Key Exclusion Criteria: Has an intolerance or hypersensitivity to any amphotericin B (AMB) product, or to azole antifungal drugs Receiving antifungal therapy ...