App Impact on Quality of Life and Symptoms in PCOS
ConditionPolycystic Ovary Syndrome (PCOS)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorEndo Health GmbH
About this trial
This study investigates the influence of a PCOS app on the quality of life and symptoms of individuals with polycystic ovary syndrome (PCOS). The intervention group can use the app over the study period of twelve weeks in addition to care-as-usual (CAU). In the control group, this is compared with no use of the PCOS-App for a twelve-week period, that is, care-as-usual only/ continuation of the current treatment (waitlist design). The aim is to evaluate the effectiveness of the app and to gain insights for the design of future studies. The study is expected to last seven months and include 220 participants.
Eligibility criteria
Qualifiers
Legal capacity
Resident in Germany
Female gender
Age ≥18 years up to 65 years
Disqualifiers
Changes in hormone therapy within eight weeks prior to the start of the study and/or planned within the next 12 weeks
Changes in treatment with metformin within eight weeks prior to the start of the study and/or planned within the next 12 weeks
Current treatment with medications for obesity (e.g., liraglutide, orlistat)
Changes in treatment with anti-androgens (e.g., spironolactone, cyproterone acetate, flutamide) within eight weeks prior to the start of the study and/or planned within the next 12 weeks
Trial design
Treatments tested in this trial
- PCOS-App
Treatment groups
220 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov