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Intimate ProtectionsR-PO19076NCT04580719

Women and Women's Hygienic Protection: Evaluation of Women's Practices, Knowledge and Expectations for Intimate Protection.

An observational study of Intimate Protections, run by CHU de Reims at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Intimate protections are designed to absorb menstrual flow during menstruation. A woman will use an average of 6,000 intimate protections during her lifetime. Intimate protections are classified into two categories: internal intimate protections including tampon, menstrual cup, menstrual sponge, and external intimate… Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Intimate Protections
How many people
1,153 participants
Where
1 siteFrance
Study dates
4 Jun 2019to 31 Dec 2019
Phase
Observational
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 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Patients aged 18 to 50, presenting menstrual cycles, consulting in the obstetrics and gynecology department of the University Hospital of Reims whatever the reason for consultation can participate in the study after signing the consent of no opposition. Participation in the study will not change the patient's medical management.

Who may be able to join

  • aged 18 to 50
  • presenting menstrual cycles

Who cannot join

  • not signing the consent of no opposition

Trial locations and contacts

1 site in 1 country.

France1 site
  • Damien JOLLY

    Reims

Other trials in France

About this study

Official title: Women and Women's Hygienic Protection: Evaluation of Women's Practices, Knowledge and Expectations for Intimate Protection

Intimate protections are designed to absorb menstrual flow during menstruation. A woman will use an average of 6,000 intimate protections during her lifetime. Intimate protections are classified into two categories: internal intimate protections including tampon, menstrual cup, menstrual sponge, and external intimate protections including disposable or washable sanitary pads, panty liner, menstrual panty. The choice and use of a type of intimate protection will depend on multiple factors specific to each woman. Due to a growing media interest in this area, women have become extremely critical and suspicious of these devices, particularly about the Toxic Shock Syndrome, attributed to the use of tampon in women previously colonized vaginally by strain of toxin-producing Staphylococcus aureus (Toxic shock syndrome toxin-1 (TSST-1)). Similarly, chemical residues have been found in sanitary napkins.

As a result, women's expectations have changed and there is a greater demand for transparency with regard to intimate protection of their composition and their potential health risks. Women want more and more alternative to conventional intimate protections in today's climate of increasing environmental awareness.

Read more

It is a cross-sectional, observational, prospective, unicentric inclusion study (CHU de Reims). The primary objective is to describe women's intimate protection practices. The secondary objectives are to study the determinants of women's choice for intimate protection, to describe women's knowledge of the potential risks of these intimate protections. and women's information sources on intimate protections. Finally describe the expectations of women in terms of intimate protections. The results are intended to give a photograph of the practices and knowledge of women consulting in the Obstetrics and Gynecology Department of the University Hospital of Reims concerning intimate protections.

Patients aged 18 to 50, presenting menstrual cycles, consulting in the obstetrics and gynecology department of the University Hospital of Reims whatever the reason for consultation can participate in the study after signing the consent of no opposition. Participation in the study will not change the patient's medical management. Participation in the study will result in the completion of a questionnaire concerning intimate protections. The filling time of the questionnaire is estimated at 10 minutes.

This subject is evolving with a growing awareness of women on the management of their rules, the products used, their potential risks and the environment. This study will allow us to see if women are really informed and feel concerned by these changes. And in the end, find out if they are ready to turn to intimate protections called "alternatives" The results will give us a vision of the expectations of our patients in this area as well as the information received, and thus allow us to publish an information guide and good practices of the intimate protections available in the waiting rooms of our consultations.

In addition, this study will allow health professionals to discuss this subject more easily and easily with their patients.

Keywords
intimate protections, CHU REIMS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04580719
Study groupRoleWhat they receive
PatientePatients aged 18 to 50, presenting menstrual cycles, consulting in the obstetrics and gynecology department of the University Hospital of Reims whatever the reason for consultation can participate in the study after signing the consent of no opposition. Participation in the study will not change the patient's medical management.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Use of tampon

    Number of patients using tampon as hygienic protection

    Measured: Day 0

  2. Use of menstrual cup menstrual sponge

    Number of patients using menstrual cup as hygienic protection

    Measured: Day 0

  3. Use of menstrual sponge

    Number of patients using menstrual sponge as hygienic protection

    Measured: Day 0

  4. Use of disposable sanitary pads

    Number of patients using disposable sanitary pads as hygienic protection

    Measured: Day 0

  5. Use of washable sanitary pads

    Number of patients using washable sanitary pads as hygienic protection

    Measured: Day 0

  6. Use of panty liner

    Number of patients using panty liner as hygienic protection

    Measured: Day 0

  7. Use of menstrual panty

    Number of patients using menstrual panty as hygienic protection

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start4 Jun 2019
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Resources

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
Other
Time perspective
Prospective
Enrolment
1,153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04580719
Sponsor's protocol ID
PO19076
Acronym
R-PO19076
Status last verified
Jun 2020
First submitted
18 Jul 2019
Last updated
8 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Intimate Protections, run by CHU de Reims 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 2 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: finished, as of the sponsor's last update on 8 Oct 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Use of tampon (time frame: Day 0). The study lists 7 primary outcomes in all. 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 8 Oct 2020.

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