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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Menstruation

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Essity Study site

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
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

Exclusion criteria

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

Treatment and study plan

Pads

Other

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

Primary outcomes

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

Secondary outcomes

Evaluation of questionnaire to understand the sleeping pattern during period

Time frame: 2025

The answers received will be assessed.

Sponsors and collaborators

Lead sponsor

Essity Hygiene and Health AB

Industry

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 15, 2024
Registry last updated: Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, Not Recruiting