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

NCT06991413 | Completed

• 1 other identifier: RCT_PilotPMS
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome; Premenstrual Syndrome-PMS

Keywords

Digital Therapeutics; Premenstrual syndrome (PMS)

Outcome Measures

Primary Outcomes (1)

• PMS-Impact Questionnaire (PMS-I)

  PMS-specific impairments, min = 18 and max=72, higher scores indicate a worse outcome

  12 weeks

Study Arms (2)

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

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.

Care-as-usual + digital PMS app

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Health GmbH: lead

Study Sites (1)

Endo Health GmbH

Chemnitz, Saxony, 09111, Germany

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 28, 2025
• Study Start: May 16, 2024
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: May 28, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)