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

Active, not recruiting

• Conditions: Menstruation

• Registration Number: NCT06637787
• Lead Sponsor: Essity Hygiene and Health AB

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-15
• Study Start: 2024-10-16
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-05-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evaluation of questionnaire to understand the sleeping pattern during period	2025	The answers received will be assessed.

Trial Locations

Locations (1)

Essity Study site; 🇸🇪 Gothenburg, Sweden