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

NCT ID: NCT06637787

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-16

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Menstruation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Pads

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Essity Hygiene and Health AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Essity Study site

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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NOKTO

Identifier Type: -

Identifier Source: org_study_id

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