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Prospective, Explorative, Research Study with Women to Investigate Menstruation Leakage At Night

Prospective, Explorative, Research Study with Women to Investigate Menstruation Leakage At Night

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06637787
Enrollment
30
Registered
2024-10-15
Start date
2024-10-16
Completion date
2025-12-30
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menstruation

Brief 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.

Interventions

OTHERPads

A specially desigend pad is used to collect information about leakage and body movement at night.

Sponsors

Essity Hygiene and Health AB
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Women ≥ 18 years 2. Participant is mentally and physically able to participate in this study 3. Written informed consent to participate in this study 4. Participant with currently heavy menstruations regularly experiencing nocturnal leakages 5. Participant is a regular user of nocturnal menstruation pads 6. Participant is willing to use the prototype pad according to the protocol 7. Willingness to take picture of used pads and transfer to study sponsor anonymously during study duration 8. Available internet connection and device for taking pictures and data transfer (photo upload) 9. Underwear size M or L

Exclusion criteria

1. Known allergies or intolerances to one or several components of the study prototype 2. Participants without regular menstruation, pregnant or perimenopausal subjects 3. Participants not experiencing nocturnal leakages 4. Participants with pacemakers and/or implant defibrillator or having persons in the household that have a pacemaker and/or implant defibrillator

Design outcomes

Primary

MeasureTime frameDescription
Summary of leakage data of the menstruation pad in correlation with participats movements and position at leakage occasion.2025Leakage data and body movement will be assessed

Secondary

MeasureTime frameDescription
Evaluation of questionnaire to understand the sleeping pattern during period2025The answers received will be assessed.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026