Ignite Creation Date:
2024-05-06 @ 1:57 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04171947
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2019-11-13
Brief Title:
Vaginal Ovule With Flavonoid Tea Extract for the Correction of Imbalance in the Vaginal Environment
Sponsor:
Value Outcomes Ltd
Organization:
Value Outcomes Ltd
Study Overview
Official Title:
Medical Device Matuzalem Flavonoid Tea Extract Vaginal Ovule for the Correction of the Imbalance in the Vaginal Environment- Prospective Multicentric Two-arm Randomized Vehicle-controlled Blinded Comparative Clinical Trial
Status:
COMPLETED
Status Verified Date:
2019-11
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:
MAT072017
Brief Summary:
Randomized blinded vehicle-controlled multicenter clinical trial MAT072017 to determine the effect of vaginal ovules containing 2 mg of the tea extract Matuzalem on the subjective symptoms 5-point scale pruritus itching dolor pain rubor redness fluor discharge and fetor odor and objective symptoms pH Nugent score of bacterial vaginosis An ovule containing only the vehicle polyethylene glycol 3000 S was used as a control The study was blinded from the perspective of the subject investigator laboratory personnel and data analyst
Detailed Description:
The objective was to determine whether vaginal ovule with tea extract once-daily for 5-7 days improves symptoms of intermediate vaginal flora and prevents the development of bacterial vaginosis
Composite primary endpoint designed as a drop in the Nugent score vaginal pH or improvement of subjective symptoms was compared between the active and vehicle polyethylene-glycol arm after 7 days of application and following 7 days after the application
Secondary outcome measures were 1 Correction of the vaginal environment as previously defined 7 days after the completion of the prescribed 7-day regimen day 14 2 change in each parameter separately 3 change in individual subjective symptoms 4 exploratory analysis of the microbial environment at each subject visit
The study was approved and supervised by the National authority and Ethics committee and prospectively registered in the Czech national medical device trial registry RZPRO and the European medical device trial registry EUDAMED
Composite primary endpoint designed as a drop in the Nugent score vaginal pH or improvement of subjective symptoms was compared between the active and vehicle polyethylene-glycol arm after 7 days of application and following 7 days after the application
Secondary outcome measures were 1 Correction of the vaginal environment as previously defined 7 days after the completion of the prescribed 7-day regimen day 14 2 change in each parameter separately 3 change in individual subjective symptoms 4 exploratory analysis of the microbial environment at each subject visit
The study was approved and supervised by the National authority and Ethics committee and prospectively registered in the Czech national medical device trial registry RZPRO and the European medical device trial registry EUDAMED
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