Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519799
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-13
Brief Title:
Integrated Genetic and Functional Analysis of the Influence of Menstrual Hygiene Products on Female Health
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Integrated Genetic and Functional Analysis of the Influence of Menstrual Hygiene Products on Female Health
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Luna
Brief Summary:
Womens reproductive health has attracted increasing attention in recent years including in the field of microbiology Vaginal infections such as vulvovaginal candidiasis bacterial vaginosis and aerobic vaginitis are common and a huge burden on our society The vaginal microbiome is important in the prevention of these infections in fertility and for healthy pregnancies The composition and therefore the health of the vaginal microbiome is influenced by many internal and external factors including intimate health However it is not yet known how intimate health and specifically the use of menstrual hygiene products affects the microbiome and womens intimate comfort and health In this study the researchers aim to understand the influence of 5 menstrual hygiene products tampon menstrual cup menstrual pad and 2 types of menstrual underwear on womens intimate health n 100 First this will be evaluated at the microbiome level focusing on the female intimate microbiome consisting of the skin in the groin vulvar and vaginal microbiome These sites are all closely linked and are affected in vaginal infections or by contact with menstrual hygiene products Second in addition to the direct impact on the microbiome the impact on the participants immune system will be evaluated as some well-known menstrual hygiene products can cause irritation and inflammation As a third goal participants will assess the comfort and usability of each menstrual hygiene product and provide data on their lifestyle and other factors that may influence our results The main goal is to investigate and define the impact of menstrual hygiene products on womens intimate health so that women can make an informed choice In a first phase participants n 1500 will fill in a survey containing questions on general health lifestyle and menstrual health Based on these responses a selection of 100 participants will be made by the researchers to participate in the intervention trial
Detailed Description:
None
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