Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • PCOS-App

    Device

    The PCOS-App helps to implement multimodal self-help measures in the daily lives of PCOS patients through various functions such as symptom diary and interactive exercises.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Polycystic Ovary Syndrome Questionnaire (PCOSQ-G)

Time frame
From enrollment to the end of treatment at 12 weeks

Secondary outcomes

1

Body Appreciation Scale - 2 (BAS-2)

Time frame
From enrollment to the end of treatment at 12 weeks
2

Patient Activation Measure 13 (PAM-13)

Time frame
From enrollment to the end of treatment at 12 weeks
3

Depression Anxiety Stress Scale 21 Items (DASS-21)

Time frame
From enrollment to the end of treatment at 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Endo Health GmbH

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: