An interventional study of Menstrual hygiene products in Vaginal Disease and Menstrual Discomfort, sponsored by University Hospital, Antwerp. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Basic science
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.
163 studies on the registry are indexed under Vaginal Diseases; 13 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 143 interventional studies indexed under Vaginal Diseases.
Browse Vaginal Diseases studies →University Hospital, Antwerp is the lead sponsor of 234 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Also known as: Menstrual cup, tampon, Menstrual pad, Menstrual underwear with cotton crotch, Menstrual underwear with non-cotton crotch
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.
Time frame: Each month for 3 samplepoints until study completion, an average of 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Each month for 3 samplepoints until study completion, an average of 6 months
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Plan to share: No
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University Hospital, Antwerp