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

NCT06991413 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2025-05-28

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Endo Health GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-16
Primary Completion
2024-10-25
Completion
2024-10-25

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06991413 on ClinicalTrials.gov