Ignite Creation Date:
2024-05-06 @ 1:15 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01762670
Status:
TERMINATED
Last Update Posted:
2015-02-03
First Post:
2013-01-04
Brief Title:
GoldenCareTM for the Treatment of Bacterial Vaginosis
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 GoldenCareTM for the Treatment of Bacterial Vaginosis
Status:
TERMINATED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company decided to stop study for reasons other than safety
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
GoldenCare is a copper intravaginal device that may be useful for the treatment of symptomatic bacterial Vaginosis BV Standard treatment for BV is metronidazole Although the reported cure rate is as high as 90 the recurrence rate is 58 after 12 months The study hypothesis is that GoldenCare will cure BV This is a proof of concept study to collect preliminary evidence of the safety and efficacy of GoldenCare
Detailed Description:
GoldenCare is a copper intravaginal device that may be useful for the treatment of symptomatic bacterial VaginosisBV Standard treatment for BV is metronidazole Although the reported cure rate is as high as 90 the recurrence rate is 58 after 12 months The study hypothesis is that GoldenCare will cure BV This is a proof of concept study to collect preliminary evidence of the safety and efficacy of GoldenCare
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