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

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.

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Key information

Conditions

Premenstrual Syndrome Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Premenstrual Syndrome-PMS

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Endo Health GmbH

Chemnitz, Saxony, 09111, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

PMS-Impact Questionnaire (PMS-I)

Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Endo Health GmbH

Industry

Registry information

Official study title

Pilot Study to Investigate the Impact of an App on the Quality of Life and Symptoms of Individuals Affected by Premenstrual Syndrome

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: May 28, 2025
Registry last updated: May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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