Polycystic Ovary Syndrome (PCOS)NCT06912594
App Impact on Quality of Life and Symptoms in PCOS
A study testing PCOS-App in people with Polycystic Ovary Syndrome (PCOS), run by Endo Health GmbH at 1 site in Germany.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- PCOS-App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- 2 Apr 2025to Sep 2025
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Legal capacity
- Resident in Germany
- Female gender
- Age ≥18 years up to 65 years
- Diagnosed and medically confirmed Polycystic Ovary Syndrome (E28.2)
- Ownership of a smartphone with a compatible iOS or Android version and the ability to operate it
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- Internet access and an email address for registration, app usage, and completing questionnaires
- Willingness to complete questionnaires online
- Motivation to use the app regularly
- Sufficient knowledge of the German language
Who cannot join
- 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
- Pregnancy or breastfeeding
- Current hormonal fertility treatment
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- Changes in treatment with psychotropic medications within eight weeks prior to the start of the study and/or planned within the next 12 weeks
- Current psychotherapeutic treatment
- Previous or current access to the Endo-App or other digital health applications (DiGAs)
- Current participation in other clinical studies
- Current nutritional counseling according to §20 SGB V or nutritional therapy according to §43 SGB V, or participation in weight reduction programs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Endo Health GmbH
Chemnitz, Saxony, 09111
Teresa Götz, M.Sc., +49 371 33560304, teresa@endometriose.app
About this study
Official title: Pilot Study to Investigate the Influence of an App on the Quality of Life and Symptoms of Patients With Polycystic Ovary Syndrome
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.
Read the detailed description
The study aims to investigate the effect of a PCOS app on quality of life and symptoms of individuals with polycystic ovary syndrome (PCOS). PCOS is a widespread and distressing health problem that can significantly affect quality of life and well-being of affected individuals. Research into digital health applications has shown the potential to provide innovative solutions to improve care and self-management of chronic conditions.
The present study is designed as a single-blind, two-arm, randomised controlled trial in which participants will either receive the PCOS app over a 12-week period in addition to care-as-usual (intervention group) or only care-as-usual as typically available (control group). The study will be conducted online. The aim is to evaluate the effectiveness of the app by analysing various questionnaires as endpoints. The primary endpoint is the Polycystic Ovary Syndrome Questionnaire (PCOSQ-G). The questionnaires/endpoints will be completed at T0 (baseline) and after 12 weeks. Statistical analyses will be conducted using R and SPSS. Exploratory evaluations of change scores in the relevant questionnaires will be performed.
Overall, this study aims to provide important insights into whether and to what extent a PCOS app can have a positive impact on the quality of life and symptoms of women with PCOS.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- PCOS-App
- Keywords
- PCOS, Quality of Life, Digital Therapeutics
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCOS-AppDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Control group has access to care-as-usual only. |
| Intervention Group | Experimental | The intervention group has access to the PCOS app and its functions in in addition to care-as-usual Receives: Device: PCOS-App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polycystic Ovary Syndrome Questionnaire (PCOSQ-G)
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (3)
Body Appreciation Scale - 2 (BAS-2)
Measured: From enrollment to the end of treatment at 12 weeks
Patient Activation Measure 13 (PAM-13)
Measured: From enrollment to the end of treatment at 12 weeks
Depression Anxiety Stress Scale 21 Items (DASS-21)
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start2 Apr 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endo Health GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912594
- Sponsor's protocol ID
- RCT_PilotPCOS
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate the Influence of an App on the Quality of Life and Symptoms of Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06912594
- Acronym / sponsor ID
- RCT_PilotPCOS
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- PCOS, Quality of Life, Digital Therapeutics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Endo Health GmbHIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 6 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.
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.
Detailed description
The study aims to investigate the effect of a PCOS app on quality of life and symptoms of individuals with polycystic ovary syndrome (PCOS). PCOS is a widespread and distressing health problem that can significantly affect quality of life and well-being of affected individuals. Research into digital health applications has shown the potential to provide innovative solutions to improve care and self-management of chronic conditions.
The present study is designed as a single-blind, two-arm, randomised controlled trial in which participants will either receive the PCOS app over a 12-week period in addition to care-as-usual (intervention group) or only care-as-usual as typically available (control group). The study will be conducted online. The aim is to evaluate the effectiveness of the app by analysing various questionnaires as endpoints. The primary endpoint is the Polycystic Ovary Syndrome Questionnaire (PCOSQ-G). The questionnaires/endpoints will be completed at T0 (baseline) and after 12 weeks. Statistical analyses will be conducted using R and SPSS. Exploratory evaluations of change scores in the relevant questionnaires will be performed.
Overall, this study aims to provide important insights into whether and to what extent a PCOS app can have a positive impact on the quality of life and symptoms of women with PCOS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Control group has access to care-as-usual only. |
| Intervention Group | Experimental | Device: PCOS-AppThe intervention group has access to the PCOS app and its functions in in addition to care-as-usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Legal capacity
- Resident in Germany
- Female gender
- Age ≥18 years up to 65 years
- Diagnosed and medically confirmed Polycystic Ovary Syndrome (E28.2)
Key exclusion criteria (11 listed)
- 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
- Pregnancy or breastfeeding
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 |
|---|---|---|
| PCOS-AppThe 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. | Device | Intervention Group |
Primary outcome
Polycystic Ovary Syndrome Questionnaire (PCOSQ-G)
Time frame: From enrollment to the end of treatment at 12 weeks
3 secondary outcomes
Body Appreciation Scale - 2 (BAS-2)
Time frame: From enrollment to the end of treatment at 12 weeks
Patient Activation Measure 13 (PAM-13)
Time frame: From enrollment to the end of treatment at 12 weeks
Depression Anxiety Stress Scale 21 Items (DASS-21)
Time frame: From enrollment to the end of treatment at 12 weeks
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 6 Apr 2025.
- Individual participant dataSharing planned: No
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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 PCOS-App in people with Polycystic Ovary Syndrome (PCOS), run by Endo Health GmbH at 1 site in Germany.
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 10 inclusion and 11 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 6 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 Germany. 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 Teresa Götz, M.Sc. (+49 371 33560304, teresa@endometriose.app), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polycystic Ovary Syndrome Questionnaire (PCOSQ-G) (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2025.