DysmenorrheaMGANCT07457957
Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents
A study testing Menstrual Tracker and Education Application in people with Dysmenorrhea and Heavy Menstrual Bleeding, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The aim of this study is to improve menstrual health-related quality of life in adolescents by using a mobile menstrual health tracker. We will perform a randomized controlled trial to evaluate the (cost)-effectiveness of this mHealth intervention. Read more about this study
- Who is it for?
- Ages 12 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea, Heavy Menstrual Bleeding, Menstrual Cramps
- What is being tested?
- Menstrual Tracker and Education Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 874 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Feb 2026to 31 May 2029
- 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 12 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Dutch, English, Turkish or Moroccan-Arabic speaking
- Post menarche
- Access to a smartphone or tablet with iOS or Android operating system
Who cannot join
- Amenorrhea
- Pregnancy
- No menstrual bleeding or withdrawel bleeding in the 3 months prior to inclusion.
- Previously or currently under treatment by a health care provider for menstrual complaints
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Amsterdam UMC
Amsterdam, 1105AZ
Esther Domenie, +31 6 23997219, MGA-studie@amsterdamumc.nl
About this study
Official title: The Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents - A Randomised Controlled Trial
The aim of this study is to improve menstrual health-related quality of life in adolescents by using a mobile menstrual health tracker. We will perform a randomized controlled trial to evaluate the (cost)-effectiveness of this mHealth intervention.
Read the detailed description
Studies have shown that menstrual health-related quality of life is influenced mainly by pain, blood loss and school/work/leisure absenteeism. We hypothesize that using a mHealth intervention designed for adolescents will increase the self-awareness of an adolescent's menstrual health, including adequate healthcare-seeking. As a result, the intervention will increase menstrual health-related quality of life.
Postmenarchal adolescents aged between 12 and 22 years can be included in this study and will be randomised using 1:1 stratified randomisation in the intervention arm or control arm. Stratification factors are: age (<16 of ≥ 16 years old), use of hormonal anticonception (yes or no) and menstrual disturbance score (Period ImPact and Pain Assessment score <3 or ≥3).
Participants in the intervention arm will be asked to track their menstrual complaints in the mobile menstrual tracker and education application daily for at least three months. Participants in the control arm will not use the mobile menstrual tracker and education application for six months. Participants in the control arm also get access to the mobile menstrual tracker and education application six months after enrollment and after the primary outcome measurement at 6-months after enrollment.
The primary outcome measure is quality of life, using the PedsQL measured six months after enrollment. Secondary outcomes are school, work and leisure absenteeism, menstrual careseeking behavior, knowledge about menstrual complaints, the prevalence of suspected bleeding disorders, the prevalence of menstrual disturbance, the amount of menstrual blood loss, and societal costs.
All outcomes will be measured using online questionnaires send at 6, 12 and 24 months after enrollment.
- Conditions
- Dysmenorrhea, Heavy Menstrual Bleeding, Menstrual Cramps, Menstrual Bleeding, Heavy, Menstrual Discomfort, Menstrual Cycle Abnormal
- Being tested
- Menstrual Tracker and Education Application
- Keywords
- randomized clinical trial, mHealth, Menstrual health, Adolescent, Menstrual Tracker App
- Medical subject headings
- Dysmenorrhea, Menorrhagia, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menstrual Tracker and Education ApplicationOther
The intervention is a mobile menstrual tracker and education application developed by Amsterdam UMC researchers. The app is developed to provide insight into the users' menstrual health and contains 11 trackable domains (menstrual bleeding, pain, impact, general health, mood, urine/stool, sleep, exercise, diet, sex, notes). It is connected to an online environment where the user gets educated about normal and abnormal menstrual health.
| Study group | Role | What they receive |
|---|---|---|
| App group | Experimental | Participants in the 'App group' arm will be asked to record their menstrual health complaints daily in the mobile menstrual tracker and education application. Receives: Other: Menstrual Tracker and Education Application |
| Waitlist group | No intervention | Participants in the 'waitlist group' will not directly get access to the mobile menstrual tracker and education application. They will be put on a 'waitlist'. Six months after inclusion and after completing the 6-month questionnaire, participants will get access to the application and are free to install and use it if desired. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Score
Quality of life measured at baseline and 6 months after enrollment using the validated Pediatric Quality of Life 4.0 questionnaire.
Measured: 6 months after enrollment
Secondary outcomes (8)
Menstrual bleeding related quality of life
The menstrual bleeding related quality of life assessed with the (adolescent) Menstrual Bleeding Questionnaire. The adolescent (<18) or adult version of the questionnaire will be used as appropriate.
Measured: 6, 12, 24 months after enrollment
Knowledge about menstrual health
The knowledge about menstrual health will be assessed with the Menstrual Health Literacy survey.
Measured: 6, 12 and 24 months after enrollment
School-, work-, and leisure absences
The impact of menstrual complaints on school, work and leisure activities will be measured using the iMTA Productivity Cost Questionnaire (iPCQ). Impact of menstrual complaints is also reported in the mobile menstrual tracker and education app.
Measured: 6, 12 and 24 months after enrollment
Societal costs
Societal costs including healthcare use and prodictivity loss will be assessed using the iMTA Productivity Cost Questionnaire (iPCQ) and the iMTA Medical Consumption Questionnaire (iMCQ).
Measured: 6, 12 and 24 months after enrollment
Quality of Life for cost-effectiveness calculation
To calculate the cost-effectiveness of the intervention, the quality of life assessed with the 5-level EQ-5D (EQ-5D-5L) and EQ-5D-Y-5L as appropriate as a measure for effectiveness.
Measured: 6, 12 and 24 months after enrollment
Participants' experience of effectiveness
The effectiveness experienced by the participant is measured using the 1-item questionnaire Patient Global Impression of Change.
Measured: 6, 12 and 24 months after enrollment
Dose of mobile menstrual tracking and education application
Logdata of the mobile menstrual tracking and education application will be used to calculate the dose of the intervention received.
Measured: 6, 12 and 24 months
Menstrual disturbance
The menstrual disturbance score assessed with the Period ImPact and Pain Assessment tool (PIPPA)
Measured: 6, 12 and 24 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start16 Feb 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 874 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Robert A. de Leeuw, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457957
- Sponsor's protocol ID
- MGA-studie
- Other IDs
- 10390032310035
- Acronym
- MGA
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ozcan H, Burger NB, Dulmen-den Broeder EV, van Baal MW, den Boogaard EV, De Leeuw RA, Huirne JAF. Instruments to Identify Menstrual Complaints and Their Impact on Adolescents: A Systematic Review. J Pediatr Adolesc Gynecol. 2024 Apr;37(2):106-120. doi: 10.1016/j.jpag.2023.11.011. Epub 2023 Dec 16.
PubMed 38104798Ozcan H, Burger NB, Derksen ME, Peute LW, Huirne JAF, De Leeuw RA. The differences between adults and adolescents using a mobile health application for menstrual complaints: A usability and qualitative study. Int J Med Inform. 2024 May;185:105382. doi: 10.1016/j.ijmedinf.2024.105382. Epub 2024 Feb 23.
PubMed 38437753
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07457957
- Acronym / sponsor ID
- MGA / MGA-studie
- Conditions
- Dysmenorrhea, Heavy Menstrual Bleeding, Menstrual Cramps, Menstrual Bleeding, Heavy, Menstrual Discomfort, Menstrual Cycle Abnormal
- Keywords
- randomized clinical trial, mHealth, Menstrual health, Adolescent, Menstrual Tracker App
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 874 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 16 Feb 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 9 Mar 2026 (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 aim of this study is to improve menstrual health-related quality of life in adolescents by using a mobile menstrual health tracker. We will perform a randomized controlled trial to evaluate the (cost)-effectiveness of this mHealth intervention.
Detailed description
Studies have shown that menstrual health-related quality of life is influenced mainly by pain, blood loss and school/work/leisure absenteeism. We hypothesize that using a mHealth intervention designed for adolescents will increase the self-awareness of an adolescent's menstrual health, including adequate healthcare-seeking. As a result, the intervention will increase menstrual health-related quality of life.
Postmenarchal adolescents aged between 12 and 22 years can be included in this study and will be randomised using 1:1 stratified randomisation in the intervention arm or control arm. Stratification factors are: age (<16 of ≥ 16 years old), use of hormonal anticonception (yes or no) and menstrual disturbance score (Period ImPact and Pain Assessment score <3 or ≥3).
Participants in the intervention arm will be asked to track their menstrual complaints in the mobile menstrual tracker and education application daily for at least three months. Participants in the control arm will not use the mobile menstrual tracker and education application for six months. Participants in the control arm also get access to the mobile menstrual tracker and education application six months after enrollment and after the primary outcome measurement at 6-months after enrollment.
The primary outcome measure is quality of life, using the PedsQL measured six months after enrollment. Secondary outcomes are school, work and leisure absenteeism, menstrual careseeking behavior, knowledge about menstrual complaints, the prevalence of suspected bleeding disorders, the prevalence of menstrual disturbance, the amount of menstrual blood loss, and societal costs.
All outcomes will be measured using online questionnaires send at 6, 12 and 24 months after enrollment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App group | Experimental | Other: Menstrual Tracker and Education ApplicationParticipants in the 'App group' arm will be asked to record their menstrual health complaints daily in the mobile menstrual tracker and education application. |
| Waitlist group | No intervention | –Participants in the 'waitlist group' will not directly get access to the mobile menstrual tracker and education application. They will be put on a 'waitlist'. Six months after inclusion and after completing the 6-month questionnaire, participants will get access to the application and are free to install and use it if desired. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Dutch, English, Turkish or Moroccan-Arabic speaking
- Post menarche
- Access to a smartphone or tablet with iOS or Android operating system
Key exclusion criteria (4 listed)
- Amenorrhea
- Pregnancy
- No menstrual bleeding or withdrawel bleeding in the 3 months prior to inclusion.
- Previously or currently under treatment by a health care provider for menstrual complaints
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 |
|---|---|---|
| Menstrual Tracker and Education ApplicationThe intervention is a mobile menstrual tracker and education application developed by Amsterdam UMC researchers. The app is developed to provide insight into the users' menstrual health and contains 11 trackable domains (menstrual bleeding, pain, impact, general health, mood, urine/stool, sleep, exercise, diet, sex, notes). It is connected to an online environment where the user gets educated about normal and abnormal menstrual health. | Other | App group |
Primary outcome
Quality of Life Score
Time frame: 6 months after enrollment
Quality of life measured at baseline and 6 months after enrollment using the validated Pediatric Quality of Life 4.0 questionnaire.
8 secondary outcomes
Menstrual bleeding related quality of life
Time frame: 6, 12, 24 months after enrollment
Knowledge about menstrual health
Time frame: 6, 12 and 24 months after enrollment
School-, work-, and leisure absences
Time frame: 6, 12 and 24 months after enrollment
Societal costs
Time frame: 6, 12 and 24 months after enrollment
Quality of Life for cost-effectiveness calculation
Time frame: 6, 12 and 24 months after enrollment
Participants' experience of effectiveness
Time frame: 6, 12 and 24 months after enrollment
Dose of mobile menstrual tracking and education application
Time frame: 6, 12 and 24 months
Menstrual disturbance
Time frame: 6, 12 and 24 months after enrollment
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 9 Mar 2026.
- Background: PubMed 38104798Ozcan H, Burger NB, Dulmen-den Broeder EV, van Baal MW, den Boogaard EV, De Leeuw RA, Huirne JAF. Instruments to Identify Menstrual Complaints and Their Impact on Adolescents: A Systematic Review. J Pediatr Adolesc Gynecol. 2024 Apr;37(2):106-120. doi: 10.1016/j.jpag.2023.11.011. Epub 2023 Dec 16.
- Background: PubMed 38437753Ozcan H, Burger NB, Derksen ME, Peute LW, Huirne JAF, De Leeuw RA. The differences between adults and adolescents using a mobile health application for menstrual complaints: A usability and qualitative study. Int J Med Inform. 2024 May;185:105382. doi: 10.1016/j.ijmedinf.2024.105382. Epub 2024 Feb 23.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menstrual Tracker and Education Application in people with Dysmenorrhea and Heavy Menstrual Bleeding, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Mar 2026. 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 Netherlands. 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 Esther Domenie, MSc (+31 6 23997219, MGA-studie@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Score (time frame: 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07457957, which also lists 2 linked publications.
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 9 Mar 2026.