Impact of an App on the Quality of Life and Symptoms in I... | NCT06991413

Studies
Impact of an App on the Quality of Life and Symptoms in Individuals With Premenstrual Syndrome

NCT06991413

Sponsor

Endo Health GmbH

Status

Completed

Last Update Posted

May 28, 2025Actual

Enrollment

175Actual

Phase

Not Applicable

Conditions

Premenstrual Syndrome
Premenstrual Syndrome-PMS

Interventions

PMS App

Countries

Germany

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

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 16, 2024Actual

Primary Completion Date

Oct 25, 2024Actual

Completion Date

Oct 25, 2024Actual

First Submitted Date

Apr 28, 2025

First Submission Date that Met QC Criteria

May 23, 2025

First Posted Date

May 28, 2025Actual

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

May 23, 2025

Last Update Posted Date

May 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This pilot study explored the effectiveness and acceptance of a digital app for the self-management of PMS. A total of 175 participants were randomized into an intervention and a control group. Findings indicate that the app offers beneficial effects on PMS-specific symptoms and broader health aspects such as fatigue and emotional well-being. The study also provided valuable insights for the design of future larger trials and highlights the promising potential of the app to enhance individualized care.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

175Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Care-as-usual	No Intervention	Control group has access to care-as-usual only
Care-as-usual + digital PMS app	Experimental	The intervention group has access to the PMS app and its functions in in addition to care-as-usual	Device: PMS App

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PMS App	Device	The PMS App helps to implement multimodal self help measures in the daily lives of PMS patients through various functions such as symptom diary and interactive exercises.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PMS-Impact Questionnaire (PMS-I)	PMS-specific impairments, min = 18 and max=72, higher scores indicate a worse outcome	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Legal capacity
Residency in Germany
Female gender
Age ≥18 years
Diagnosed and medically confirmed current PMS (N94.3)
Ownership of a smartphone and ability to use it
Internet access for app usage and questionnaire completion
Email address for registration
Willingness to complete questionnaires online
Motivation for regular app usage
Sufficient proficiency in the German language

Exclusion Criteria:

Pregnancy, breastfeeding, or the onset of menopause during the study period
Changes in hormonal therapy and/or use of antidepressants within eight weeks prior to the study start and/or planned in the upcoming 12 weeks
Previous or current access to the Endo-App or other comparable digital health applications, or current active prescription
Current participation in other clinical studies
Failure to meet the inclusion criteria

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

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Endo Health GmbH		Chemnitz	Saxony	09111	Germany

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

Condition Browse Module

MeSH Terms

ID	Term
D011293	Premenstrual Syndrome

Ancestor Terms

ID	Term
D008599	Menstruation Disturbances
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided