Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04489290
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-26
First Post:
2020-07-24
Brief Title:
Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis
Sponsor:
Pharmiva AB
Organization:
Pharmiva AB
Study Overview
Official Title:
A Randomised Double-blind and Placebo-controlled Post Market Clinical Follow-Up Investigation to Investigate the Clinical Performance of a Medical Device on Clinical Signs and Symptoms and the Vaginal Environment in Patients With Bacterial Vaginosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
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:
None
Brief Summary:
This is a randomised double-blind clinical investigation to evaluate the efficacy and safety of D005 vaginal mousse compared to placebo in women with bacterial vaginosis
The study will be conducted at one site in Scotland United Kingdom and at six different sites in Sweden The study population will consist of approximately 83 female subjects
The study will be conducted at one site in Scotland United Kingdom and at six different sites in Sweden The study population will consist of approximately 83 female subjects
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