MenstruationNCT06637787
Prospective, Explorative, Research Study with Women to Investigate Menstruation Leakage At Night
An observational study of Menstruation, run by Essity Hygiene and Health AB at 1 site in Sweden.
Trial summary
The aim of this study is to investigate why and when menstruation leakages occur during sleep while using protective pads at night. Participants will be asked to use a specially designed pad during menstruation and to answer questions. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menstruation
- What is being tested?
- Pads
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 16 Oct 2024to 30 Dec 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with heavy menstruation
Who may be able to join
- Women ≥ 18 years
- Participant is mentally and physically able to participate in this study
- Written informed consent to participate in this study
- Participant with currently heavy menstruations regularly experiencing nocturnal leakages
- Participant is a regular user of nocturnal menstruation pads
- Participant is willing to use the prototype pad according to the protocol
Show all 9Show fewer
- Willingness to take picture of used pads and transfer to study sponsor anonymously during study duration
- Available internet connection and device for taking pictures and data transfer (photo upload)
- Underwear size M or L
Who cannot join
- Known allergies or intolerances to one or several components of the study prototype
- Participants without regular menstruation, pregnant or perimenopausal subjects
- Participants not experiencing nocturnal leakages
- Participants with pacemakers and/or implant defibrillator or having persons in the household that have a pacemaker and/or implant defibrillator
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate why and when menstruation leakages occur during sleep while using protective pads at night. Participants will be asked to use a specially designed pad during menstruation and to answer questions.
- Conditions
- Menstruation
- Being tested
- Pads
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PadsOther
A specially desigend pad is used to collect information about leakage and body movement at night.
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of leakage data of the menstruation pad in correlation with participats movements and position at leakage occasion.
Leakage data and body movement will be assessed
Measured: 2025
Secondary outcomes (1)
Evaluation of questionnaire to understand the sleeping pattern during period
The answers received will be assessed.
Measured: 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start16 Oct 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenstruationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essity Hygiene and Health AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637787
- Sponsor's protocol ID
- NOKTO
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 19 Mar 2025
- 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Explorative, Research Study with Women to Investigate Menstruation Leakage At Night
- ClinicalTrials.gov ID
- NCT06637787
- Acronym / sponsor ID
- NOKTO
- Conditions
- Menstruation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 Oct 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.
The aim of this study is to investigate why and when menstruation leakages occur during sleep while using protective pads at night. Participants will be asked to use a specially designed pad during menstruation and to answer questions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with heavy menstruation
Key inclusion criteria (9 listed)
- Women ≥ 18 years
- Participant is mentally and physically able to participate in this study
- Written informed consent to participate in this study
- Participant with currently heavy menstruations regularly experiencing nocturnal leakages
- Participant is a regular user of nocturnal menstruation pads
Key exclusion criteria (4 listed)
- Known allergies or intolerances to one or several components of the study prototype
- Participants without regular menstruation, pregnant or perimenopausal subjects
- Participants not experiencing nocturnal leakages
- Participants with pacemakers and/or implant defibrillator or having persons in the household that have a pacemaker and/or implant defibrillator
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 |
|---|---|---|
| PadsA specially desigend pad is used to collect information about leakage and body movement at night. | Other | – |
Primary outcome
Summary of leakage data of the menstruation pad in correlation with participats movements and position at leakage occasion.
Time frame: 2025
Leakage data and body movement will be assessed
1 secondary outcome
Evaluation of questionnaire to understand the sleeping pattern during period
Time frame: 2025
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 19 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Menstruation, run by Essity Hygiene and Health AB at 1 site in Sweden.
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 9 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2025. 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 Sweden. 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?
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?
Summary of leakage data of the menstruation pad in correlation with participats movements and position at leakage occasion. (time frame: 2025). 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 19 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.