CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 137 enrolled
Drug / intervention
Oral Encochleated Amphotericin B (CAMB) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02971007
NCT02971007Phase 2Completed
CompareCT.gov

A Multi-Center Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) Compared With Oral Fluconazole in the Treatment of Moderate to Severe Vulvovaginal Candidiasis (VVC)

Matinas BioPharma Nanotechnologies, Inc.·interventional·Posted Nov 22, 2016·Updated Nov 2, 2018

In Brief

A Phase 2 clinical trial evaluating Oral Encochleated Amphotericin B (CAMB) and Fluconazole for Vulvovaginitis and 3 related conditions. Completed, enrolled 137 participants across 23 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvovaginitis, Yeast Infection, Yeast Infection Vaginal, Candidiasis, Vulvovaginal
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 22, 2016
Enrollment StartNov 1, 2016
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 9.6 years ago

Interventions

Oral Encochleated Amphotericin B (CAMB)drug

lipid-crystal nano-particle formulation amphotericin B

Fluconazoledrug