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

NCT04734405 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2022-09-22

No results posted yet for this study

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.

Conditions

  • Recurrent Vulvovaginal Candidiasis

Interventions

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

Sponsors & Collaborators

  • Montavit Ges.m.b.H.

    collaborator INDUSTRY

  • ProFem GmbH

    lead INDUSTRY

Principal Investigators

  • Herbert Kiss, Prof. · Universitätsklinik für Frauenheilkunde

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2022-11-01
Completion
2022-12-30

Countries

  • Austria
  • Poland
  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04734405 on ClinicalTrials.gov