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

Antwerp University Hospital (UZA)

Status: Enrolling

Conditions: Vaginal Disease; Menstrual Discomfort

Treatments: Other: Menstrual hygiene products

Study type: Interventional

Funder types: Other

Identifiers

NCT06519799

EDGE003611

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Combination pill

Experimental group

Description:

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.

Treatment:

Other: Menstrual hygiene products

No-hormonal contracteption

Experimental group

Description:

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.

Treatment:

Other: Menstrual hygiene products