Sexual Transmitted DiseaseCUPS2NCT07199998
Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota
An observational study of Sexual Transmitted Disease and Vaginosis, Bacterial, run by Centre National de la Recherche Scientifique, France at 1 site in France.
Trial summary
The availability, effectiveness, and safety of menstrual protection represent a key public health issue. However, research on women's menstrual and sexual health remains extremely limited. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Transmitted Disease, Vaginosis, Bacterial, Mycosis
- What is being tested?
- Samples collection (whole blood, urine, vaginal and cervical cells)
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population includes individuals of the female sex, aged 18 to 49 years, who have already experienced at least one menstrual period and meet the inclusion criteria. Participants are residents of the Île-de-France region and are recruited either through the Alfred Fournier Institute or via an online epidemiological survey.
Who may be able to join
- Willingness to comply with all study procedures and availability for the duration of the study.
- Female, aged 18 to 49 years.
- In general good health, as determined by medical history.
- Covered by the national health insurance system.
- Willing to sign a written informed consent form.
- Has already experienced menstruation prior to the start of the study.
- No vaginal sexual intercourse within 72 hours before the study visit.
- Has had at least 6 menstrual periods in the past 12 months.
Who cannot join
- HIV infection.
- Positive diagnosis for chlamydia or syphilis at screening or within 4 weeks prior to screening.
- History of hormonal disorders or menstrual cycle irregularities.
- Metrorrhagia.
- Pregnancy or breastfeeding.
- Family members or close relatives of the clinical or scientific team.
Show all 12Show fewer
- Treatment with any medication for chronic inflammatory disease or chronic conditions (e.g., cancer, arthritis, transplantation) within the past 12 months.
- Participation in an ongoing clinical trial.
- Receiving or having received antibiotic treatment within the 4 weeks prior to the study.
- Refusal to be informed in case of detected abnormalities.
- Indistinct use of both tampons and menstrual cups.
- Never having had vaginal penetrative intercourse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical team contact
France1 site, 1 recruiting
- Recruiting
Institut Alfred Fournier
Paris, Île-de-France Region, 75014
About this study
Official title: Impact of the Use of Internal Menstrual Protections on Immunity and Vaginal Microbiota
The availability, effectiveness, and safety of menstrual protection represent a key public health issue. However, research on women's menstrual and sexual health remains extremely limited. Whether societal or pathological, many hypotheses are emerging regarding the effects of menstrual protection products, yet little attention has been given to the products themselves, their societal role, or their physiological and pathological consequences. Internal menstrual products, such as tampons and menstrual cups, are widely used but are subject to limited regulatory oversight, and few studies have investigated their long-term effects on vaginal health.
This study aims to investigate how different types of menstrual protection influence vaginal microbiota, immune responses, and the recurrence of gynecological conditions such as bacterial vaginosis, mycosis, or dysbiosis. Biological samples (vaginal, cervical, urinary, and blood) will be collected to analyze vaginal microbiota composition and local immunity. Participants will be divided into three groups based on their main type of menstrual protection: menstrual cup users, tampon users, and external pad users. The study will compare these groups to assess potential differences in vaginal health and immune response related to menstrual product use.
Read the detailed description
The aim of this study is to investigate potential links between the type of menstrual protection used and variations in vaginal health, including microbial composition, immune responses, and exposure to environmental pollutants.
The project consists of two complementary components:
- Epidemiological Study: An online survey will be conducted with 1,500 to 1,800 participants, collecting detailed information on the usage habits of menstrual protection products (such as menstrual cups, tampons, and external pads), as well as self-reported symptoms and history of urogenital infections. This dataset will allow for large-scale correlation analyses between menstrual hygiene practices and women's health indicators.
- Clinical Study:
A total of approximately 300 women will be recruited and divided into three groups based on their primary menstrual protection method:
Group 1: Menstrual cup users Group 2: Tampon users Group 3: External sanitary pad users
All clinical participants will undergo a gynecological examination and provide vaginal, cervical, urinary, and blood samples. These biological samples will be used for in-depth analysis across three main areas:
- Microbiology: studying the vaginal microbiota composition and identifying infectious or dysbiotic profiles.
- Immunology: assessing local immune responses, including cytokine levels and antibody titers.
- Toxicology: measuring exposure to potential environmental pollutants through menstrual product use.
Sequencing, immune profiling, pollutant quantification, and cytobacteriological screening will be conducted to evaluate potential differences between groups. These analyses aim to provide a better understanding of how menstrual protection methods may influence vaginal ecosystem balance, immune activity, and overall urogenital health.
- Conditions
- Sexual Transmitted Disease, Vaginosis, Bacterial, Mycosis, Urogenital Disease, HPV, Dysbiosis
- Being tested
- Samples collection (whole blood, urine, vaginal and cervical cells)
- Keywords
- Menstrual cup, Dysbiosis, Menstrual health, Menstrual protection, Menstrual pad, Tampon, Immunity
- Medical subject headings
- Sexually Transmitted Diseases, Vaginosis, Bacterial, Mycoses, Urogenital Diseases, Dysbiosis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samples collection (whole blood, urine, vaginal and cervical cells)Other
During the clinical visit, samples will be collected from participants, including blood, urine, and vaginal and cervical cells. These samples will be used for a range of analyses, including determination of the vaginal microbiota composition and sequencing, cytokine profiling, and assessment of local immunity through flow cytometry using CyTOF technology. Urine samples will be analyzed for pollutants such as phthalates and bisphenol, while blood samples will be used for blood cell counts.
| Study group | Role | What they receive |
|---|---|---|
| Tampon-only user | This group includes participants who have been using single-use tampons as their main form of menstrual protection in the past six months. Receives: Other: Samples collection (whole blood, urine, vaginal and cervical cells) | |
| Cups-only user | This group includes participants who have used reusable menstrual cups as their main form of protection in the past six months. Receives: Other: Samples collection (whole blood, urine, vaginal and cervical cells) | |
| External-only user | This group includes participants who have not used any internal menstrual products in the past six months, relying instead on external protection such as sanitary pads. Receives: Other: Samples collection (whole blood, urine, vaginal and cervical cells) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effect of the use of internal menstrual products on the composition of the vaginal microbiota.
To investigate potential differences in microbiota between study groups, the investigators will perform metagenomics next-generation sequencing on vaginal swabs.
Measured: Samples will be stored at -80°C and metagenomics sequencing will be performed within 24 months after collection.
Secondary outcomes (2)
Comparison of the vaginal immune response of users and non-users of internal menstrual products
Description of the cellular composition from vaginal and cervical samples (CyTOF technique) and measurement of vaginal cytokines.
Since this is a cross-sectional study, all the measures are made at inclusion, i.e. at baseline.
Measured: Samples for this purpose will be prepared for preservation immediately after collection. After preparation, they will be stored at -80°C and subsequently shipped for the analyses.
Effect of the type of internal menstrual protections on the presence of pollutants in urine.
Quantification of parabens and other pollutants in urine samples or other samples.
Measured: Urine samples will be stored at -80°C and analysed within 24 months after collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start7 Apr 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual Transmitted DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre National de la Recherche Scientifique, France
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Alfred Fournier
- Responsible party
- Principal investigator, Samuel Alizon, Centre National de la Recherche Scientifique, France
- Investigators
- Samuel Alizon, Doctor in Biology, Principal investigator, Centre National de la Recherche Scientifique, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199998
- Sponsor's protocol ID
- 2024-A00597-40
- Acronym
- CUPS2
- Status last verified
- Apr 2026
- First submitted
- 20 Aug 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participants who wish to be informed about the results of the research will receive information in French about the scientific publications via a newsletter or posts on social media (e.g. mastodon).
Publications
Tessandier N, Uysal IB, Elie B, Selinger C, Bernat C, Boue V, Grasset S, Groc S, Rahmoun M, Reyne B, Bender N, Bonneau M, Graf C, Tribout V, Foulongne V, Ravel J, Waterboer T, Hirtz C, Bravo IG, Reynes J, Segondy M, Murall CL, Boulle N, Kamiya T, Alizon S. Does exposure to different menstrual products affect the vaginal environment? Mol Ecol. 2023 May;32(10):2592-2601. doi: 10.1111/mec.16678. Epub 2022 Oct 4.
PubMed 36057782
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of Internal Menstrual Protections on Immunity and Vaginal Microbiota
- ClinicalTrials.gov ID
- NCT07199998
- Acronym / sponsor ID
- CUPS2 / 2024-A00597-40
- Conditions
- Sexual Transmitted Disease, Vaginosis, Bacterial, Mycosis, Urogenital Disease, HPV, Dysbiosis
- Keywords
- Menstrual cup, Dysbiosis, Menstrual health, Menstrual protection, Menstrual pad, Tampon, Immunity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre National de la Recherche Scientifique, FranceUniversity, hospital or other
- Collaborators
- Institut Alfred Fournier
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Sep 2025 (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.
The availability, effectiveness, and safety of menstrual protection represent a key public health issue. However, research on women's menstrual and sexual health remains extremely limited. Whether societal or pathological, many hypotheses are emerging regarding the effects of menstrual protection products, yet little attention has been given to the products themselves, their societal role, or their physiological and pathological consequences. Internal menstrual products, such as tampons and menstrual cups, are widely used but are subject to limited regulatory oversight, and few studies have investigated their long-term effects on vaginal health.
This study aims to investigate how different types of menstrual protection influence vaginal microbiota, immune responses, and the recurrence of gynecological conditions such as bacterial vaginosis, mycosis, or dysbiosis. Biological samples (vaginal, cervical, urinary, and blood) will be collected to analyze vaginal microbiota composition and local immunity. Participants will be divided into three groups based on their main type of menstrual protection: menstrual cup users, tampon users, and external pad users. The study will compare these groups to assess potential differences in vaginal health and immune response related to menstrual product use.
Detailed description
The aim of this study is to investigate potential links between the type of menstrual protection used and variations in vaginal health, including microbial composition, immune responses, and exposure to environmental pollutants.
The project consists of two complementary components:
- Epidemiological Study: An online survey will be conducted with 1,500 to 1,800 participants, collecting detailed information on the usage habits of menstrual protection products (such as menstrual cups, tampons, and external pads), as well as self-reported symptoms and history of urogenital infections. This dataset will allow for large-scale correlation analyses between menstrual hygiene practices and women's health indicators.
- Clinical Study:
A total of approximately 300 women will be recruited and divided into three groups based on their primary menstrual protection method:
Group 1: Menstrual cup users Group 2: Tampon users Group 3: External sanitary pad users
All clinical participants will undergo a gynecological examination and provide vaginal, cervical, urinary, and blood samples. These biological samples will be used for in-depth analysis across three main areas:
- Microbiology: studying the vaginal microbiota composition and identifying infectious or dysbiotic profiles.
- Immunology: assessing local immune responses, including cytokine levels and antibody titers.
- Toxicology: measuring exposure to potential environmental pollutants through menstrual product use.
Sequencing, immune profiling, pollutant quantification, and cytobacteriological screening will be conducted to evaluate potential differences between groups. These analyses aim to provide a better understanding of how menstrual protection methods may influence vaginal ecosystem balance, immune activity, and overall urogenital health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tampon-only user | – | Other: Samples collection (whole blood, urine, vaginal and cervical cells)This group includes participants who have been using single-use tampons as their main form of menstrual protection in the past six months. |
| Cups-only user | – | Other: Samples collection (whole blood, urine, vaginal and cervical cells)This group includes participants who have used reusable menstrual cups as their main form of protection in the past six months. |
| External-only user | – | Other: Samples collection (whole blood, urine, vaginal and cervical cells)This group includes participants who have not used any internal menstrual products in the past six months, relying instead on external protection such as sanitary pads. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population includes individuals of the female sex, aged 18 to 49 years, who have already experienced at least one menstrual period and meet the inclusion criteria. Participants are residents of the Île-de-France region and are recruited either through the Alfred Fournier Institute or via an online epidemiological survey.
Key inclusion criteria (8 listed)
- Willingness to comply with all study procedures and availability for the duration of the study.
- Female, aged 18 to 49 years.
- In general good health, as determined by medical history.
- Covered by the national health insurance system.
- Willing to sign a written informed consent form.
Key exclusion criteria (12 listed)
- HIV infection.
- Positive diagnosis for chlamydia or syphilis at screening or within 4 weeks prior to screening.
- History of hormonal disorders or menstrual cycle irregularities.
- Metrorrhagia.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Samples collection (whole blood, urine, vaginal and cervical cells)During the clinical visit, samples will be collected from participants, including blood, urine, and vaginal and cervical cells. These samples will be used for a range of analyses, including determination of the vaginal microbiota composition and sequencing, cytokine profiling, and assessment of local immunity through flow cytometry using CyTOF technology. Urine samples will be analyzed for pollutants such as phthalates and bisphenol, while blood samples will be used for blood cell counts. | Other | Cups-only user, External-only user, Tampon-only user |
Primary outcome
Determine the effect of the use of internal menstrual products on the composition of the vaginal microbiota.
Time frame: Samples will be stored at -80°C and metagenomics sequencing will be performed within 24 months after collection.
To investigate potential differences in microbiota between study groups, the investigators will perform metagenomics next-generation sequencing on vaginal swabs.
2 secondary outcomes
Comparison of the vaginal immune response of users and non-users of internal menstrual products
Time frame: Samples for this purpose will be prepared for preservation immediately after collection. After preparation, they will be stored at -80°C and subsequently shipped for the analyses.
Effect of the type of internal menstrual protections on the presence of pollutants in urine.
Time frame: Urine samples will be stored at -80°C and analysed within 24 months after collection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 36057782Tessandier N, Uysal IB, Elie B, Selinger C, Bernat C, Boue V, Grasset S, Groc S, Rahmoun M, Reyne B, Bender N, Bonneau M, Graf C, Tribout V, Foulongne V, Ravel J, Waterboer T, Hirtz C, Bravo IG, Reynes J, Segondy M, Murall CL, Boulle N, Kamiya T, Alizon S. Does exposure to different menstrual products affect the vaginal environment? Mol Ecol. 2023 May;32(10):2592-2601. doi: 10.1111/mec.16678. Epub 2022 Oct 4.
- French webpage of the study cohortLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Participants who wish to be informed about the results of the research will receive information in French about the scientific publications via a newsletter or posts on social media (e.g. mastodon).
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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.
Clinical team contact
Samuel Alizon, Doctor in Biology principal investigator
Centre National de la Recherche Scientifique, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Transmitted Disease and Vaginosis, Bacterial, run by Centre National de la Recherche Scientifique, France at 1 site in France.
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 8 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel Alizon, Dr (+33(4)144271667, samuel.alizon@cnrs.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the effect of the use of internal menstrual products on the composition of the vaginal microbiota. (time frame: Samples will be stored at -80°C and metagenomics sequencing will be performed within 24 months after collection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07199998, which also lists 1 linked publication.
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 9 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.