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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06991413

Enrollment

175

Registered

2025-05-28

Start date

2024-05-16

Completion date

2024-10-25

Last updated

2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premenstrual Syndrome, Premenstrual Syndrome-PMS

Keywords

Digital Therapeutics, Premenstrual syndrome (PMS)

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.

Interventions

DEVICEPMS 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Caregiver, Investigator)

Intervention model description

Randomised controlled trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026