Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450990
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-30
Brief Title:
Efficacy Safety and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection
Sponsor:
NEXBIOME THERAPEUTICS
Organization:
NEXBIOME THERAPEUTICS
Study Overview
Official Title:
Efficacy Safety and Dose-response of a Live Biotherapeutic Product BGY-1601-VT as a First-line Monotherapy in Women With Acute Vaginal Infection a Randomized Double-blind Placebo-controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELINA
Brief Summary:
The purpose of this clinical trial is to investigate the clinical efficacy and safety of a Live Biotherapeutic Product BGY-1601-VT intended as a first line of treatment in cases of acute vaginal infection without upfront microbiological confirmed diagnosis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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