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

NCT06519799 | Unknown

• 1 other identifier: EDGE003611
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaginal Disease; Menstrual Discomfort

Keywords

menstrual health; intimate health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• relative abundance of eigentaxa

  Each month for 3 samplepoints until study completion, an average of 6 months

• comfort and ease of use

  Periodically, after menstruation once a month.

• alfa diversity of the vaginal microbiome

  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

  Each month for 3 samplepoints until study completion, an average of 6 months

Study Arms (2)

Combination pill

EXPERIMENTAL

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

No-hormonal contracteption

EXPERIMENTAL

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

Interventions

Menstrual hygiene products OTHER

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

Also known as: Menstrual cup, tampon, Menstrual pad, Menstrual underwear with cotton crotch, Menstrual underwear with non-cotton crotch

Combination pill; No-hormonal contracteption

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: people who menstruate
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Universiteit Antwerpen: collaborator
• Research Foundation Flanders: collaborator

Study Sites (1)

University of Antwerp

Antwerp, 2020, Belgium

RECRUITING

MeSH Terms

Conditions

Vaginal Diseases

Interventions

Menstrual Hygiene Products

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Feminine Hygiene Products; Equipment and Supplies

Central Study Contacts

Veronique Verhoeven, Professor

CONTACT

+3232652518; veronique.verhoeven@uantwerpen.be

Sarah Lebeer, Professor

CONTACT

+3232653285; sarah.lebeer@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As the intervention is the use of a menstrual product, no masking is possible.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will wear all 5 menstrual products in a randomized order.

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: July 25, 2024
• Study Start: August 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: October 31, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)