Viewing Study NCT03167957



Ignite Creation Date: 2024-05-06 @ 10:07 AM
Last Modification Date: 2024-10-26 @ 12:25 PM
Study NCT ID: NCT03167957
Status: WITHDRAWN
Last Update Posted: 2019-03-08
First Post: 2017-05-23

Brief Title: Efficacy and Safety of Oral Encochleated Amphotericin B CAMB in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis
Sponsor: Matinas BioPharma Nanotechnologies Inc
Organization: Matinas BioPharma Nanotechnologies Inc

Study Overview

Official Title: A Single-Center Open-Label Pilot Study to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B CAMB in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis
Status: WITHDRAWN
Status Verified Date: 2019-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: No longer target indication
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: 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

Approximately 16 women with fluconazole-resistant VVC will be randomized to either 200 mg or 400 mg oral CAMB for 14 days The primary objectives of this study are to assess the clinical cure rate mycology eradication and responder outcome The secondary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None