NCT07457957

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
874

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Feb 2026May 2029

Study Start

First participant enrolled

February 16, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

March 4, 2026

Last Update Submit

March 4, 2026

Conditions

DysmenorrheaMenstrual CrampsMenstrual Bleeding, HeavyMenstrual DiscomfortMenstrual Cycle AbnormalMenstrual DisorderMenstrual HealthMobile ApplicationmHealthMenstrual Health InterventionAdolescentHeavy Menstrual Bleeding

Keywords

randomized clinical trialmHealthMenstrual healthAdolescentMenstrual Tracker App

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months after enrollment

Secondary Outcomes (8)

  • Menstrual bleeding related quality of life

    6, 12, 24 months after enrollment

  • Knowledge about menstrual health

    6, 12 and 24 months after enrollment

  • School-, work-, and leisure absences

    6, 12 and 24 months after enrollment

  • Societal costs

    6, 12 and 24 months after enrollment

  • Quality of Life for cost-effectiveness calculation

    6, 12 and 24 months after enrollment

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

App group

Eligibility Criteria

Age12 Years - 21 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Dutch, English, Turkish or Moroccan-Arabic speaking
  • Post menarche
  • Access to a smartphone or tablet with iOS or Android operating system

You may not qualify if:

  • Amenorrhea
  • Pregnancy
  • Previously or currently under treatment by a health care provider for menstrual complaints

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC

Amsterdam, 1105AZ, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 38104798BACKGROUND

  • 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.

    PMID: 38437753BACKGROUND

MeSH Terms

Conditions

DysmenorrheaMenorrhagiaMenstruation Disturbances

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and SymptomsUterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhage

Central Study Contacts

Esther Domenie, MSc

CONTACT

+31 6 23997219MGA-studie@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD. Principal Investigator

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 9, 2026

Study Start

February 16, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

May 31, 2029

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

NL(1)