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

NCT ID: NCT06519799

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Menstrual hygiene products

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Menstrual hygiene products

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

Menstrual cup; tampon; Menstrual pad; Menstrual underwear with cotton crotch; Menstrual underwear with non-cotton crotch

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universiteit Antwerpen

OTHER

Sponsor Role: collaborator

Research Foundation Flanders

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Antwerp

Antwerp, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Veronique Verhoeven, Professor

Role: CONTACT

veronique.verhoeven@uantwerpen.be

+3232652518

Sarah Lebeer, Professor

Role: CONTACT

sarah.lebeer@uantwerpen.be

+3232653285

Facility Contacts

Veronique Verhoeven, Professor

Role: primary

veronique.verhoeven@uantwerpen.be

+3232652518

Sarah Lebeer, Professor

Role: backup

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

EDGE003611

Identifier Type: -

Identifier Source: org_study_id