Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04734405
Study type Interventional
Source ProFem GmbH
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date October 1, 2019
Completion date December 30, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05074602 - A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Recurrent Vulvovaginal Candidiasis Phase 3
Completed NCT04029116 - Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC) Phase 3
Completed NCT01067131 - Safety and Immunogenicity Study of a Virosomal Vaccine Against Recurrent Vulvovaginal Candida Infection Phase 1
Completed NCT03840616 - Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections Phase 3
Recruiting NCT04699240 - Study of Lactobacillus in Adjuvant Treatment of RVVC Phase 4
Not yet recruiting NCT04639544 - Effect of a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis N/A
Completed NCT02267382 - A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) Phase 2
Recruiting NCT06190509 - Assessing the Safety, Immune Response, and Early Efficacy of a Candida Vaccine in Women With Recurrent Vulvovaginal Candidiasis: A Randomized Controlled Study Phase 1/Phase 2
Completed NCT03561701 - A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) Phase 3
Completed NCT03562156 - A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) Phase 3
Completed NCT05795491 - Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis N/A
Completed NCT03059992 - Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment Phase 3