Prospective, Explorative, Research Study with Women to In... | NCT06637787

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

NCT06637787

Sponsor

Essity Hygiene and Health AB

Status

Active, not recruiting

Last Update Posted

Mar 19, 2025Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Menstruation

Interventions

Pads

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 16, 2024Actual

Primary Completion Date

May 30, 2025Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Oct 9, 2024

First Submission Date that Met QC Criteria

Oct 9, 2024

First Posted Date

Oct 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2025

Last Update Posted Date

Mar 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pads	Other	A specially desigend pad is used to collect information about leakage and body movement at night.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women with heavy menstruation

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided