drugset / Trial / NCT04734405
A Phase IIb/III Study of Prof-001 for the Treatment of Patients With Recurrent Vulvovaginal Candidiasis (RVVC)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a prospective, randomized, multi-center, active-controlled, double-blind, double-dummy, multicenter, non-inferiority study comparing the clinical efficacy, safety and tolerability of ProF-001 to fluconazole.
Timeline
- Start
- 2019-10-01
- Primary completion
- 2022-11-01
- Completion
- 2022-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluconazole | Small molecule | 150 mg | Oral |
| Subject | Prof-001 | Unknown | 2.5 g | Topical |