Vaginal DiseaseLunaNCT06519799
Integrated Genetic and Functional Analysis of the Influence of Menstrual Hygiene Products on Female Health
A study testing Menstrual hygiene products in people with Vaginal Disease and Menstrual Discomfort, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Disease, Menstrual Discomfort
- What is being tested?
- Menstrual hygiene products
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female
- contraception: combination pill with stop week or no hormonal contraception
- premenopausal
- Dutch-speaking living in Belgium
- regular menstrual cycle (if no hormonal contraception)
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University of Antwerp
Antwerp, 2020
Veronique Verhoeven, Professor, +3232652518, veronique.verhoeven@uantwerpen.be
Sarah Lebeer, Professor
About this study
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
- Being tested
- Menstrual hygiene products
- Keywords
- menstrual health, intimate health
- Medical subject headings
- Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menstrual hygiene productsOther
Also called Menstrual cup, tampon, Menstrual pad, Menstrual underwear with cotton crotch
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Menstrual hygiene products |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each month for 3 samplepoints until study completion, an average of 6 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Each month for 3 samplepoints until study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will wear all 5 menstrual products in a randomized order.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen, Research Foundation Flanders
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519799
- Sponsor's protocol ID
- EDGE003611
- Acronym
- Luna
- Status last verified
- Jan 2024
- First submitted
- 13 May 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Genetic and Functional Analysis of the Influence of Menstrual Hygiene Products on Female Health
- ClinicalTrials.gov ID
- NCT06519799
- Acronym / sponsor ID
- Luna / EDGE003611
- Conditions
- Vaginal Disease, Menstrual Discomfort
- Keywords
- menstrual health, intimate health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen, Research Foundation Flanders
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant will wear all 5 menstrual products in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Combination pill | Experimental | Other: Menstrual hygiene productsThis 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. |
| No-hormonal contracteption | Experimental | Other: Menstrual hygiene productsThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- female
- contraception: combination pill with stop week or no hormonal contraception
- premenopausal
- Dutch-speaking living in Belgium
- regular menstrual cycle (if no hormonal contraception)
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menstrual hygiene productsAlso: Menstrual cup, tampon, Menstrual pad, Menstrual underwear with cotton crotchThe 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 | Combination pill, No-hormonal contracteption |
Primary outcome
Beta diversity of the vaginal microbiome
Time frame: Each month for 3 samplepoints until study completion, an average of 6 months
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.
4 secondary outcomes
relative abundance of eigentaxa
Time frame: Each month for 3 samplepoints until study completion, an average of 6 months
comfort and ease of use
Time frame: Periodically, after menstruation once a month.
alfa diversity of the vaginal microbiome
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
Time frame: Each month for 3 samplepoints until study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menstrual hygiene products in people with Vaginal Disease and Menstrual Discomfort, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronique Verhoeven, Professor (+3232652518, veronique.verhoeven@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta diversity of the vaginal microbiome (time frame: Each month for 3 samplepoints until study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.