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.

Study Overview

• Status: Active, not recruiting
• Conditions: Menstruation
• Intervention / Treatment: Other: Pads

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Essity Study site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women with heavy menstruation

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of questionnaire to understand the sleeping pattern during period	The answers received will be assessed.	2025

Collaborators and Investigators

• Sponsor: Essity Hygiene and Health AB

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NOKTO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No