Integrated Genetic and Functional Analysis of the Influence of Menstrual Hygiene Products on Female Health (Luna)

Women's 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 women's 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 women's 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 participant's 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 women's 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.

Study Overview

• Status: Recruiting
• Conditions: Vaginal Disease; Menstrual Discomfort
• Intervention / Treatment: Other: Menstrual hygiene products

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veronique Verhoeven, Professor; Phone Number: +3232652518; Email: veronique.verhoeven@uantwerpen.be
• Study Contact Backup: Name: Sarah Lebeer, Professor; Phone Number: +3232653285; Email: sarah.lebeer@uantwerpen.be

Study Locations

• Belgium
  • Antwerp, Belgium, 2020
    • Recruiting
    • University of Antwerp
    • Principal Investigator: Sarah Lebeer, Professor
    • Contact: Veronique Verhoeven, Professor; Phone Number: +3232652518; Email: veronique.verhoeven@uantwerpen.be
    • Contact: Sarah Lebeer, Professor
    • Sub-Investigator: Leonore Vander Donck, PhD student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• female
• contraception: combination pill with stop week or no hormonal contraception
• premenopausal
• Dutch-speaking living in Belgium
• regular menstrual cycle (if no hormonal contraception)

Exclusion Criteria:

• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination pill; This arm ( n = 50) is selected based on their contraception use, under the combination pill your menstruation and composition of menstrual blood is altered. In this arm all participants will wear all 5 menstrual products, 1 product per menstruation. The order of products will be randomized over this arm.	Other: Menstrual hygiene products; The influence on the intimate health of each product will be evaluated. As you can't not use a menstrual product during menstruation, no control group is included; Other Names: Menstrual cup; tampon; Menstrual pad; Menstrual underwear with cotton crotch; Menstrual underwear with non-cotton crotch
Experimental: No-hormonal contracteption; This arm (n = 50) is selected based on the use of no hormonal contraception, to investigate a natural menstrual cycle. In this arm all participants will wear all 5 menstrual products, 1 product per menstruation. The order of products will be randomized over this arm.	Other: Menstrual hygiene products; The influence on the intimate health of each product will be evaluated. As you can't not use a menstrual product during menstruation, no control group is included; Other Names: Menstrual cup; tampon; Menstrual pad; Menstrual underwear with cotton crotch; Menstrual underwear with non-cotton crotch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beta diversity of the vaginal microbiome	This measure describes the taxonomic diversity between samples, a higher diversity is associated with a less healthy vaginal microbiome. Beta diversity within a participant over all products will be calculated as a stability measure. This will be defined for each participant comparing the baseline samples (right before menstruation) to the sample during and after menstruation. Comparison will be made between different menstrual hygiene products.	Each month for 3 samplepoints until study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
relative abundance of eigentaxa	The relative abundance of some eigentaxa such as Lactobacillus crispatus will be looked at, as this is known to be associated with some menstrual products. The relative abundance at each samplepoint will be evaluated at the end of the study, comparison will be made between the different menstrual hygiene products.	Each month for 3 samplepoints until study completion, an average of 6 months
comfort and ease of use	the participants will answer evaluate the comfort and ease of use of each product, during the survey at the timepoint after each menstruation for each product.	Periodically, after menstruation once a month.
alfa diversity of the vaginal microbiome	this measure describes the taxonomic diversity within a sample. The alfa diversity within a participant over all products will be calculated as a measure of stability. This will be defined for each participant comparing the baseline samples (right before menstruation) to the sample during and after menstruation. Comparison will be made between different menstrual hygiene products.	Each month for 3 samplepoints until study completion, an average of 6 months
both alfa and beta diversity of the vulvar and groin skin microbiome	these measures describe the taxonomic diversity. Comparison will be made between different menstrual hygiene products.	Each month for 3 samplepoints until study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Universiteit Antwerpen; Research Foundation Flanders

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: menstrual health; intimate health
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginal Diseases
• Other Study ID Numbers: EDGE003611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No