Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646185
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Improving Menstrual and VAginal Health for All
Sponsor:
None
Organization:
None
Study Overview
Official Title:
IMVAHA Improving Menstrual and VAginal Health for All
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
IMVAHA
Brief Summary:
A three-period crossover trial will study the effects of short-term use of 3 menstrual products menstrual pad tampon menstrual cup on the bacterial composition of the vaginal microbiome in three countries Peru Cameroon and Switzerland Each crossover period consists of two menstrual cycles thus resulting in a 6-month trial Participants will be randomly assigned to one of 6 exposure sequences different order of products per sequence in each sequence participants will adopt each menstrual product for 2 menstrual cycles Participants will provide vaginal microbiome samples via self-sample swabs at 3 points during each menstrual cycle Given the crossover design of the study there is not a dedicated control group
Detailed Description:
In three countries the investigators will follow a randomized crossover design to study the effects of menstrual products on the vaginal microbiome composition and diversity Eligible participants who are willing to adopt pads tampons and menstrual cups to manage their menstruation and for which baseline composition of their vaginal microbiomes is determined through DNA sequencing of the 16s rRNA gene will enter a three-period crossover trial Each period of the trial will consist of two menstrual cycles thus resulting in a 6-month trial Participants will be randomly assigned to one of six different exposure sequences of menstrual products as follows
i Tampon Cup Pad ii Tampon Pad Cup iii Cup Tampon Pad iv Cup Pad Tampon v Pad Tampon Cup vi Pad Cup Tampon
In group i participants will adopt tampons during the first two menstrual cycles first period of the trial followed by the adoption of cups during the next two menstrual cycles second period and lastly menstrual pads for the next two menstrual cycles third crossover period In groups ii to vi following the same design but in different sequences Self-sampling kits will be provided during six consecutive menstrual cycles a few days before the start of menses Each kit will contain swabs for three self-sampling points during the menstrual cycle and the corresponding menstrual products
i Tampon Cup Pad ii Tampon Pad Cup iii Cup Tampon Pad iv Cup Pad Tampon v Pad Tampon Cup vi Pad Cup Tampon
In group i participants will adopt tampons during the first two menstrual cycles first period of the trial followed by the adoption of cups during the next two menstrual cycles second period and lastly menstrual pads for the next two menstrual cycles third crossover period In groups ii to vi following the same design but in different sequences Self-sampling kits will be provided during six consecutive menstrual cycles a few days before the start of menses Each kit will contain swabs for three self-sampling points during the menstrual cycle and the corresponding menstrual products
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