drugset / Trial / NCT04734405

A Phase IIb/III Study of Prof-001 for the Treatment of Patients With Recurrent Vulvovaginal Candidiasis (RVVC)

NCT04734405

Phase 2/3 Unknown 432 enrolled ProFem GmbH Montavit Ges.m.b.H. · collab
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

EvaluationDrugModalityDoseRoute
Comparator Fluconazole Small molecule 150 mg Oral
Subject Prof-001 Unknown 2.5 g Topical