Premenstrual SyndromeNCT06991413
Impact of an App on the Quality of Life and Symptoms in Individuals With Premenstrual Syndrome
A study testing PMS App in people with Premenstrual Syndrome and Premenstrual Syndrome-PMS, run by Endo Health GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Premenstrual Syndrome, Premenstrual Syndrome-PMS
- What is being tested?
- PMS App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteGermany
- Study dates
- 16 May 2024to 25 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Investigate the Impact of an App on the Quality of Life and Symptoms of Individuals Affected by 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.
- Conditions
- Premenstrual Syndrome, Premenstrual Syndrome-PMS
- Being tested
- PMS App
- Keywords
- Digital Therapeutics, Premenstrual syndrome (PMS)
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMS AppDevice
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 group | Role | What they receive |
|---|---|---|
| Care-as-usual | No intervention | Control group has access to care-as-usual only |
| Care-as-usual + digital PMS app | Experimental | The intervention group has access to the PMS app and its functions in in addition to care-as-usual Receives: Device: PMS App |
What is being measured
The primary outcome is the main question the study is designed to answer.
PMS-Impact Questionnaire (PMS-I)
PMS-specific impairments, min = 18 and max=72, higher scores indicate a worse outcome
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start16 May 2024
- Primary completion25 Oct 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo Health GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991413
- Sponsor's protocol ID
- RCT_PilotPMS
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 28 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate the Impact of an App on the Quality of Life and Symptoms of Individuals Affected by Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT06991413
- Acronym / sponsor ID
- RCT_PilotPMS
- Conditions
- Premenstrual Syndrome, Premenstrual Syndrome-PMS
- Keywords
- Digital Therapeutics, Premenstrual syndrome (PMS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Endo Health GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 May 2024 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Care-as-usual | No intervention | –Control group has access to care-as-usual only |
| Care-as-usual + digital PMS app | Experimental | Device: PMS AppThe intervention group has access to the PMS app and its functions in in addition to care-as-usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Legal capacity
- Residency in Germany
- Female gender
- Age ≥18 years
- Diagnosed and medically confirmed current PMS (N94.3)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMS AppThe 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. | Device | Care-as-usual + digital PMS app |
Primary outcome
PMS-Impact Questionnaire (PMS-I)
Time frame: 12 weeks
PMS-specific impairments, min = 18 and max=72, higher scores indicate a worse outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PMS App in people with Premenstrual Syndrome and Premenstrual Syndrome-PMS, run by Endo Health GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PMS-Impact Questionnaire (PMS-I) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.