DysmenorrheaMEK appNCT06921629
Menstrual Complaints in Adolescents and Adults
An observational study of 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 investigate the prevalence of menstrual complaints and their impact on daily life activities (school/work absence, absence from social activities, sports) in adults and adolescents. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Dysmenorrhea, Heavy Menstrual Bleeding, Daily Activities
- What is being tested?
- Menstruatie Educatie Kalender (Menstrution Education Calendar) application (MEK-app) and Questionnaires
- How many people
- 2,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 May 2023to 11 May 2026
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants were recruited from social media channels Facebook (@Uterine Repair Center), Instagram (@MenstruatieApp) and Tiktok (@MenstruatieEducatieApp), schools during biology class and from outpatient clinics, including pediatrics and adolescent medicine and gynecology, regardless of their reason for coming.
The inclusion criteria were
- post-menarcheal adolescents and adults aged 12-60 years,
- having a menstrual cycle with monthly bleeding (also with an intra-uterine device or use of contraceptive pills),
- speaking Dutch (MEK-app is available in Dutch only);
- having a smartphone with the operating system Android or iOS and
- obtaining informed consent from the participant and the parents of the participants aged 12-16 years.
The exclusion criteria were
- amenorrhea
- incompleted questionnaires
- not using the MEK-app for at least one period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence and Impact of Menstrual Complaints in Adolescents and Adults - a Prospective Cohort
The aim of this study is to investigate the prevalence of menstrual complaints and their impact on daily life activities (school/work absence, absence from social activities, sports) in adults and adolescents.
Read the detailed description
This study was an online prospective cohort study and consisted of using the Menstruatie Educatie Kalender (Menstruation Education Calendar) application (MEK app) daily for at least one cycle with a questionnaire before and after the use of this application. Participants consisted of postmenarchal adolescents and adults with a menstrual cycle with monthly bleeding. The study involved minimal effort for participants: a baseline questionnaire at the start of the study, requiring approximately 10 minutes; daily app use for at least one cycle, taking around 20 seconds each day; and a final questionnaire at the end of the study, lasting about 10 minutes. Participants received no compensation for participating and the use of the MEK app was free.
Previous research on menstrual complaints in adolescents has considered sample sizes of approximately 1,000 participants to be representative of the population. Since this prospective cohort study about adolescent's menstrual complaints involved repeated measurements, and the literature suggested that repeated measurements of outcome variables increase study power and reduce the required sample size, this study aimed to include a total of 900 adolescents and 900 adults.
The study results were reported using descriptive statistical analyses. To compare dichotomous outcomes the chi-square test or the Fishers' exact test was used. Depending on the data distribution, the Student's t-test or Mann-Whitney U test was used to compare continuous outcomes. Mixed effects logistic regression was used for the association between menstrual complaints and the impact on daily life activities. The statistical analysis was performed in IBM SPSS Statistics version 28 using a two-sided p-values. P-values under 0.05 were considered statistically significant.
- Conditions
- Dysmenorrhea, Heavy Menstrual Bleeding, Daily Activities, Menstrual Cramps, Menstrual Cycle, Menstrual Distress (Dysmenorrhea)
- Being tested
- Menstruatie Educatie Kalender (Menstrution Education Calendar) application (MEK-app), Questionnaires
- Keywords
- Dysmenorrhea, Heavy Menstrual Bleeding, Menstrual complaints, Impact of menstrual complaints, daily activities, Adolescents, Adults
- Medical subject headings
- Dysmenorrhea, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menstruatie Educatie Kalender (Menstrution Education Calendar) application (MEK-app)Other
The MEK-APP is a mHealth application to evaluate menstrual complaints like heavy menstrual blood loss and dysmenorrhea. The MEK-APP is a calendar and facilitates daily monitoring of pain intensity using a Visual Analogue Scale (VAS), the amount of blood loss through a pictorial blood loss assessment chart (PBAC), and the impact of these complaints on daily life. The MEK-APP followed the waterfall methodology for software development and the usability was evaluated by both adults and adolescents(4). Furthermore, the MEK app has been approved by the privacy and security officers of Amsterdam UMC
QuestionnairesOther
After registration for this study via www.mijnmenstruatie.nl (which has also been approved by the privacy and security officers of Amsterdam UMC), participants received the first digital questionnaire. This questionnaire consisted of a baseline questionnaire, the electronic self bleeding assessment tool (e-self-BATH) and the Menstrual Health Literacy questionnaire.
After using the MEK-app for at least one month, participants received an e-mail with the second questionnaire. This questionnaire consisted of the Menstrual Bleeding Questionnaire; Period ImPact and Pain Assesment; Pelvic Pain Impact Questionnaire; ENDOPAIN-4D; Endometriosis Health Profile 5 and iMTA Productivity Cost Questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents | postmenarchal adolescents between 12 and 18 years old, (according to the WHO's definition of adolescents) with monthly menstruation Receives: Other: Menstruatie Educatie Kalender (Menstrution Education Calendar) application (MEK-app); Other: Questionnaires | |
| Adults | Postmenarchal adults between 19 and 60 years with monthly menstruation Receives: Other: Menstruatie Educatie Kalender (Menstrution Education Calendar) application (MEK-app); Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of menstrual complaints (registred in the MEK-app)
The impact of menstrual complaints (bleeding and pain) on daily activities in adolescents and adults registered in the MEK-app. Impact on daily life was assessed in the MEK app with the question: "Has your menstruation affected your daily activities?" Participants could respond with "yes" or "no."
Measured: 1 month
Prevalence of menstrual complaints
Prevalence of dysmenorrhea and heavy menstrual bleeding
Measured: 1 month
Secondary outcomes (2)
Risk of clotting disorder (self-BAT questionnaire)
The risk of a clotting disorder, specifically in the groups with normal and heavy blood loss assessed with the self-BAT questionnaire. The results will be expressed as percentages of participants with increased self-BAT scores.
Measured: 1 month
Knowledge about menstruation and management, measured with the Menstrual Health Literacy survey.
The Menstrual Health Literacy Survey consisted of questions about among other things current management options for dysmenorrhea, impact of dysmenorrhea and/or pelvic pain on daily or social activities, impact of dysmenorrhea on academic performance or engagement, school and/or university support, health literacy around menstruation, sources of knowledge, what they consider normal regarding dysmenorrhea, which additional symptoms during menstruation they perceive as normal, and how they manage the pain. The questionnaire was as a mixture of closed, multiple-choice, and open-ended questions. The answers to the questions in this questionnaire will be shown in numbers and percentages
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start11 May 2023
- Primary completion11 May 2026 (estimated)
- Study completion11 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 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)
- Investigators
- Robert de Leeuw, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921629
- Sponsor's protocol ID
- MEK-app
- Acronym
- MEK app
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ozcan 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 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Impact of Menstrual Complaints in Adolescents and Adults - a Prospective Cohort
- ClinicalTrials.gov ID
- NCT06921629
- Acronym / sponsor ID
- MEK app / MEK-app
- Conditions
- Dysmenorrhea, Heavy Menstrual Bleeding, Daily Activities, Menstrual Cramps, Menstrual Cycle, Menstrual Distress (Dysmenorrhea)
- Keywords
- Dysmenorrhea, Heavy Menstrual Bleeding, Menstrual complaints, Impact of menstrual complaints, daily activities, Adolescents, Adults
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- 11 May 2026 (estimated)
- Study completion
- 11 May 2026 (estimated)
- First posted
- 10 Apr 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 aim of this study is to investigate the prevalence of menstrual complaints and their impact on daily life activities (school/work absence, absence from social activities, sports) in adults and adolescents.
Detailed description
This study was an online prospective cohort study and consisted of using the Menstruatie Educatie Kalender (Menstruation Education Calendar) application (MEK app) daily for at least one cycle with a questionnaire before and after the use of this application. Participants consisted of postmenarchal adolescents and adults with a menstrual cycle with monthly bleeding. The study involved minimal effort for participants: a baseline questionnaire at the start of the study, requiring approximately 10 minutes; daily app use for at least one cycle, taking around 20 seconds each day; and a final questionnaire at the end of the study, lasting about 10 minutes. Participants received no compensation for participating and the use of the MEK app was free.
Previous research on menstrual complaints in adolescents has considered sample sizes of approximately 1,000 participants to be representative of the population. Since this prospective cohort study about adolescent's menstrual complaints involved repeated measurements, and the literature suggested that repeated measurements of outcome variables increase study power and reduce the required sample size, this study aimed to include a total of 900 adolescents and 900 adults.
The study results were reported using descriptive statistical analyses. To compare dichotomous outcomes the chi-square test or the Fishers' exact test was used. Depending on the data distribution, the Student's t-test or Mann-Whitney U test was used to compare continuous outcomes. Mixed effects logistic regression was used for the association between menstrual complaints and the impact on daily life activities. The statistical analysis was performed in IBM SPSS Statistics version 28 using a two-sided p-values. P-values under 0.05 were considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents | – | Other: Menstruatie Educatie Kalender (Menstrution Education Calendar) application (MEK-app), Other: Questionnairespostmenarchal adolescents between 12 and 18 years old, (according to the WHO's definition of adolescents) with monthly menstruation |
| Adults | – | Other: Menstruatie Educatie Kalender (Menstrution Education Calendar) application (MEK-app), Other: QuestionnairesPostmenarchal adults between 19 and 60 years with monthly menstruation |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants were recruited from social media channels Facebook (@Uterine Repair Center), Instagram (@MenstruatieApp) and Tiktok (@MenstruatieEducatieApp), schools during biology class and from outpatient clinics, including pediatrics and adolescent medicine and gynecology, regardless of their reason for coming.
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 |
|---|---|---|
| Menstruatie Educatie Kalender (Menstrution Education Calendar) application (MEK-app)The MEK-APP is a mHealth application to evaluate menstrual complaints like heavy menstrual blood loss and dysmenorrhea. The MEK-APP is a calendar and facilitates daily monitoring of pain intensity using a Visual Analogue Scale (VAS), the amount of blood loss through a pictorial blood loss assessment chart (PBAC), and the impact of these complaints on daily life. The MEK-APP followed the waterfall methodology for software development and the usability was evaluated by both adults and adolescents(4). Furthermore, the MEK app has been approved by the privacy and security officers of Amsterdam UMC | Other | Adolescents, Adults |
| QuestionnairesAfter registration for this study via www.mijnmenstruatie.nl (which has also been approved by the privacy and security officers of Amsterdam UMC), participants received the first digital questionnaire. This questionnaire consisted of a baseline questionnaire, the electronic self bleeding assessment tool (e-self-BATH) and the Menstrual Health Literacy questionnaire. After using the MEK-app for at least one month, participants received an e-mail with the second questionnaire. This questionnaire consisted of the Menstrual Bleeding Questionnaire; Period ImPact and Pain Assesment; Pelvic Pain Impact Questionnaire; ENDOPAIN-4D; Endometriosis Health Profile 5 and iMTA Productivity Cost Questionnaire. | Other | Adolescents, Adults |
Primary outcome
Impact of menstrual complaints (registred in the MEK-app)
Time frame: 1 month
The impact of menstrual complaints (bleeding and pain) on daily activities in adolescents and adults registered in the MEK-app. Impact on daily life was assessed in the MEK app with the question: "Has your menstruation affected your daily activities?" Participants could respond with "yes" or "no."
Prevalence of menstrual complaints
Time frame: 1 month
Prevalence of dysmenorrhea and heavy menstrual bleeding
2 secondary outcomes
Risk of clotting disorder (self-BAT questionnaire)
Time frame: 1 month
Knowledge about menstruation and management, measured with the Menstrual Health Literacy survey.
Time frame: 1 month
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 10 Apr 2025.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
Robert de Leeuw, MD, PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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?
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: under way, not looking for participants, as of the sponsor's last update on 10 Apr 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 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?
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?
Impact of menstrual complaints (registred in the MEK-app) (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT06921629, which also lists 1 linked publication.
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 10 Apr 2025.