120
Participants
Start Date
December 1, 2023
Primary Completion Date
December 31, 2024
Study Completion Date
June 30, 2025
0.9% NaCl physiological saline
Vaginal-spraying 0.9% NaCl physiological saline is prepared by extracting 10 mL from 0.9% NaCl intravenous infusion 500 mL PP bottle (B.Braun, Germany, product declaration No. VD-32732-19), and then pouring it into the same opaque metallic spraying 20 mL-bottle.
LiveSpo X-secret
"In Vietnam, LiveSpo X-SECRET is manufactured as two product lines: (1) Class-A medical device product (Product declaration No.220003286/PCBA-HN) under manufacturing standards approved by Hanoi Department of Health, Ministry of Health, Vietnam and ISO 13485:2016 (Certificate No YT117-19) and (2) comestic (Product declaration No.14981/22/CBMP-HA) under manufacturing standards approved by Hanoi Department of Health, Ministry of Health, Vietnam (Certificate No 118/CNĐĐKSXMP. Both product lines have the same probiotic composition.~The cosmetic type was used for the clinical trial conducted at Hanoi OGH. The Class-A medical device type was used for the clinical trial conducted at Bac Ninh CDC."
Hanoi Obstetrics and Gynecology Hospital, Ba Dinh
Centers for Disease Control and Prevention, Bắc Ninh
Lead Sponsor
Hanoi Obstetrics and Gynecology Hospital
OTHER
Centers for Disease Control and Prevention
FED
Anabio R&D
INDUSTRY