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CompletedNCT06991413Updated May 28, 2025

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

An interventional study of PMS App in Premenstrual Syndrome and Premenstrual Syndrome-PMS, sponsored by Endo Health GmbH. Completed at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-28.

Sponsored by Endo Health GmbH · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled May 2024, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
175
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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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.

02

Conditions studied

  • Premenstrual Syndrome
  • Premenstrual Syndrome-PMS

Keywords

  • Digital Therapeutics
  • Premenstrual syndrome (PMS)
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In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's enrollment of 175 is above the median of 50 across 6,515 interventional studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

Endo Health GmbH is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
175 participants (actual)

Study arms

  • No intervention
    Care-as-usual

    Control group has access to care-as-usual only

  • Experimental
    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

    Device: PMS App

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.

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What researchers measure

Primary outcomes

  1. PMS-Impact Questionnaire (PMS-I)

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

    Time frame: 12 weeks

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Study locations

1 site
  • Endo Health GmbH
    Chemnitz, Saxony 09111, Germany
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06991413
Lead sponsor
Endo Health GmbH
Responsible party
Sponsor
First posted
May 28, 2025
Start date
May 16, 2024
Primary completion
Oct 25, 2024
Completion
Oct 25, 2024
Last update
May 28, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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