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Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)

NCT02971007 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2018-11-02

Study results available
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Summary

This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.

Conditions

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

Interventions

DRUG

Oral Encochleated Amphotericin B (CAMB)

lipid-crystal nano-particle formulation amphotericin B

DRUG

Fluconazole

Sponsors & Collaborators

  • Matinas BioPharma Nanotechnologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Douglas Kling · Matinas BioPharma Nanotechnologies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-05-31
Completion
2017-05-31

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 NCT02971007 on ClinicalTrials.gov