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

NCT06637787 | Active Not Recruiting

• 1 other identifier: NOKTO
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Menstruation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of questionnaire to understand the sleeping pattern during period

  2025

Interventions

Pads OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with heavy menstruation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Essity Hygiene and Health AB: lead

Study Sites (1)

Essity Study site

Gothenburg, Sweden

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: October 16, 2024
• Primary Completion: May 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 19, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)