Ignite Creation Date:
2024-05-06 @ 3:04 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02197182
Status:
TERMINATED
Last Update Posted:
2018-04-05
First Post:
2014-07-20
Brief Title:
LUXSOLTM Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis A Proof of Concept Study
Sponsor:
CDA Research Group Inc
Organization:
CDA Research Group Inc
Study Overview
Official Title:
An Open-Label Randomized Study to Determine the Safety and Efficacy of LUXSOLTM Cream for the Treatment of Bacterial Vaginosis A Proof of Concept Study
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not for safety reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
LUXSOL Cream may be useful for the treatment of bacterial Vaginosis In this study LUXSOL Cream is compared to a control arm group using metronidazole cream LUXSOL is administered intravaginally for 10 days each evening before bedtime to treat bacterial Vaginosis
Detailed Description:
LUXSOL Topical Cream is a copper containing topical cream indicated for the treatment of bacterial vaginosis BV The study is an open-label randomized controlled study comparing LUXSOL Cream to Metrogel in patients with a diagnosis of BV The investigational product or the comparator product will be self-administered by the patient for 10 consecutive nights A successful patient outcome is cured BV at 30 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None