NCT04734405

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

Phase IIb/III Parallel-arm, Random., Active-controlled, Double-blind, Double-dummy, Multicenter, Non-inferiority Study in Patients With RVVC to Compare Efficacy, Safety and Tolerability of Topically Administered ProF-001 to Oral Fluconazole

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 432 (estimated)
• Sponsor: ProFem GmbH · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible subjects will be randomized in a 1:1 ratio to receive either ProF-001 or fluconazole for the treatment of RVVC. Patients diagnosed with RVVC will be randomized to either ProF-001 or fluconazole treatment. Treatment schedule will start with an induction period of 10 (+4) days followed by a six months maintenance period and a subsequent 6 months follow-up (observation) period after end of active treatment. Any episode of VVC grade \> = 3 and positive vaginal smear (native or KOH) with budding yeasts, pseudohyphae or hyphae from test of cure (TOC) visit onwards will be considered as relapse of VVC.

Conditions

• Recurrent Vulvovaginal Candidiasis

Interventions

Type	Name	Description
DRUG	Prof-001	Prof-001 cream
DRUG	Fluconazole 150 mg	Fluconazole capsule
DRUG	Placebo cream	ointment base to mimic Prof-001
DRUG	Placebo capsule	encapsulated lactose powder to mimic 150 mg fluconazole capsule

Timeline

• Start date: 2019-10-01
• Primary completion: 2022-11-01
• Completion: 2022-12-30
• First posted: 2021-02-02
• Last updated: 2022-09-22

Locations

29 sites across 3 countries: Austria, Poland, Slovakia