EndometriosisMASQUENCT06821217
The Effect of an App-based Intervention on Quality of Life in Patients With Endometriosis.
A study testing NALU Endo Flow App in people with Endometriosis and Pain, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to learn if an App-based intervention affects the quality of life in patients with suspected or confirmed endometriosis. The main questions it aims to answer are: Does the App-based intervention improve the quality of life? Does it lead to pain relief? Researchers will compare… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Pain, Quality of Life
- What is being tested?
- NALU Endo Flow App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Informed Consent as documented by signature
- Age 18 or older
- Premenopausal status (menopause is defined as amenorrhea lasting one year or longer)
- Endometriosis, confirmed by surgery or clinically suspected
- Possession of a smartphone
Who cannot join
- Planned endometriosis surgery or planned hormonal therapy in the study period
- Surgery and/or new hormonal therapy in the last three months
- Malignant diseases
- Pregnancy
- Breastfeeding
- Active desire for pregnancy in the study period
- Fertility treatment
- Simultaneous participation in other intervention studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michael David Mueller, Professor, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
Department of Gynecology and Obstetrics, Women's University Hospital, Inselspital Bern, University of Bern
Bern, 3010
Michael Mueller, Professor, MD, +41 31 632 10 10, michel.mueller@insel.ch
About this study
Official title: A Mobile Application as Supportive Treatment of Endometriosis: the Effect on Quality of Life and Endometriosis-associated Pain. A Randomized Controlled Trial.
The goal of this clinical trial is to learn if an App-based intervention affects the quality of life in patients with suspected or confirmed endometriosis. The main questions it aims to answer are:
- Does the App-based intervention improve the quality of life?
- Does it lead to pain relief? Researchers will compare participants using the App to a control group to see if the App works to improve quality of life and endometriosis-related symptoms.
Participants will:
- Use an App-based intervention or be in the control group (no App-use) for 6 months
- Visit or have a telephone consultation after 3 and 6 months
- Complete a questionnaire to assess the quality of life at inclusion, after 1, 3 and 6 months
- Conditions
- Endometriosis, Pain, Quality of Life, Life Style
- Being tested
- NALU Endo Flow App
- Medical subject headings
- Endometriosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NALU Endo Flow AppDevice
NALU Endo Flow App is a mobile application for women with endometriosis. The App provides educational information through videos, audios, and texts. Women learn about endometriosis in general with its symptoms, diagnosis, and therapy options such as lifestyle and mindset modification, endometriosis-specific diets, physical and mindfulness exercises. The App includes a diary to track the menstrual cycle and symptoms. Furthermore, access to a WhatsApp community of people with endometriosis is provided and a peer-group call is performed once monthly, as well as one additional monthly Q\&A (Question\&Answer) call moderated by certified health coaches.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group with histologically confirmed endometriosis | Experimental | Not described Receives: Device: NALU Endo Flow App |
| Control group with histologically confirmed endometriosis | No intervention | Not described |
| Intervention group with clinically suspected endometriosis | Experimental | Not described Receives: Device: NALU Endo Flow App |
| Control group with clinically suspected endometriosis | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life quality
The primary endpoint will be the change in quality of life in App users assessed by the EHP-30 questionnaire (Endometriosis-Health-Profile-Questionnaire: The questions can be divided into five subscales covering 'pain', 'control and powerlessness', 'social support', 'emotional wellbeing' and 'self-image'. The questionnaire is standardized on a scale from 0 to 100, with lower scores indicating better quality of life.
Measured: 6 months
Secondary outcomes (1)
Pain relief
The secondary endpoint of this study is the change in pain intensity in App users measured by the VAS (Visual Analogue Scale). The VAS is one of various instruments to measure pain intensity. A score of 0 means "no pain", a score of 10 "the worst imaginable pain".
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marietta Gulz, MD, Principal investigator, University Hospital Bern, Insel Gruppe AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821217
- Sponsor's protocol ID
- 2023-D0105
- Acronym
- MASQUE
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Application as Supportive Treatment of Endometriosis: the Effect on Quality of Life and Endometriosis-associated Pain. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06821217
- Acronym / sponsor ID
- MASQUE / 2023-D0105
- Conditions
- Endometriosis, Pain, Quality of Life, Life Style
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 11 Feb 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.
The goal of this clinical trial is to learn if an App-based intervention affects the quality of life in patients with suspected or confirmed endometriosis. The main questions it aims to answer are:
- Does the App-based intervention improve the quality of life?
- Does it lead to pain relief? Researchers will compare participants using the App to a control group to see if the App works to improve quality of life and endometriosis-related symptoms.
Participants will:
- Use an App-based intervention or be in the control group (no App-use) for 6 months
- Visit or have a telephone consultation after 3 and 6 months
- Complete a questionnaire to assess the quality of life at inclusion, after 1, 3 and 6 months
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention group with histologically confirmed endometriosis | Experimental | Device: NALU Endo Flow App |
| Control group with histologically confirmed endometriosis | No intervention | – |
| Intervention group with clinically suspected endometriosis | Experimental | Device: NALU Endo Flow App |
| Control group with clinically suspected endometriosis | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed Consent as documented by signature
- Age 18 or older
- Premenopausal status (menopause is defined as amenorrhea lasting one year or longer)
- Endometriosis, confirmed by surgery or clinically suspected
- Possession of a smartphone
Key exclusion criteria (8 listed)
- Planned endometriosis surgery or planned hormonal therapy in the study period
- Surgery and/or new hormonal therapy in the last three months
- Malignant diseases
- Pregnancy
- Breastfeeding
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 |
|---|---|---|
| NALU Endo Flow AppNALU Endo Flow App is a mobile application for women with endometriosis. The App provides educational information through videos, audios, and texts. Women learn about endometriosis in general with its symptoms, diagnosis, and therapy options such as lifestyle and mindset modification, endometriosis-specific diets, physical and mindfulness exercises. The App includes a diary to track the menstrual cycle and symptoms. Furthermore, access to a WhatsApp community of people with endometriosis is provided and a peer-group call is performed once monthly, as well as one additional monthly Q\&A (Question\&Answer) call moderated by certified health coaches. | Device | Intervention group with clinically suspected endometriosis, Intervention group with histologically confirmed endometriosis |
Primary outcome
Life quality
Time frame: 6 months
The primary endpoint will be the change in quality of life in App users assessed by the EHP-30 questionnaire (Endometriosis-Health-Profile-Questionnaire: The questions can be divided into five subscales covering 'pain', 'control and powerlessness', 'social support', 'emotional wellbeing' and 'self-image'. The questionnaire is standardized on a scale from 0 to 100, with lower scores indicating better quality of life.
1 secondary outcome
Pain relief
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 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.
Michael David Mueller, Professor, MD contact
Marietta Gulz, MD principal investigator
University Hospital Bern, Insel Gruppe AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NALU Endo Flow App in people with Endometriosis and Pain, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 14 Feb 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marietta Gulz, MD (+41 31 632 10 10, marietta.gulz@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life quality (time frame: 6 months). 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 14 Feb 2025.