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Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis

NCT03167957 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-03-08

No results posted yet for this study

Summary

This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).

Conditions

  • Vulvovaginal Candidiases
  • Yeast Infection
  • Vulvovaginitis
  • Yeast Infection Vaginal
  • Candidiasis, Vulvovaginal

Interventions

DRUG

Oral Encochleated Amphotericin B (CAMB)

Lipid-crystal nano-particle formulation amphotericin B

DRUG

Oral Encochleated Amphotericin B (CAMB)

Lipid-crystal nano-particle formulation amphotericin B

Sponsors & Collaborators

  • Matinas BioPharma Nanotechnologies, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

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 NCT03167957 on ClinicalTrials.gov