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

NCT ID: NCT06991413

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-16
• Study Completion Date: 2024-10-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Care-as-usual

Control group has access to care-as-usual only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Care-as-usual + digital PMS app

The intervention group has access to the PMS app and its functions in in addition to care-as-usual

Group Type: EXPERIMENTAL

PMS App

Intervention Type: 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.

Interventions

PMS App

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Endo Health GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Endo Health GmbH

Chemnitz, Saxony, Germany

Countries

Germany

Other Identifiers

RCT_PilotPMS

Identifier Type: -

Identifier Source: org_study_id