Menopausal and Other Perimenopausal DisordersNCT06987617
Pilot Study to Investigate the Impact of an App on the Quality of Life and Symptoms of Individuals Affected by Menopause
A study testing Menopause App in people with Menopausal and Other Perimenopausal Disorders, run by Endo Health GmbH at 1 site in Germany.
Trial summary
The study explores the impact of a digital app for the self-management of (peri-)menopausal disorders. A total of 224 participants were randomized into an intervention and a control group. Findings indicate that the app offers beneficial effects on menopausal symptoms and menopause-specific quality-of-life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menopausal and Other Perimenopausal Disorders
- What is being tested?
- Menopause App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteGermany
- Study dates
- 9 Aug 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Legal capacity
- Residency in Germany
- Female sex
- Age ≥18 years
- Known and medically confirmed (peri-)menopausal disorder (N95.1, N95.3, N95.8, N95.9)
- Ownership of a smartphone and ability to use it
Show all 12Show fewer
- Internet access for app usage and questionnaire completion
- Email address for registration
- Willingness to complete questionnaires online
- Motivation for regular app usage
- Sufficient proficiency in the German language
- Absence of exclusion criteria
Who cannot join
- Changes in hormone therapy within eight weeks before the start of the study and/or planned within the next 12 weeks
- Changes in antidepressant treatment within eight weeks before the start of the study and/or planned within the next 12 weeks
- Previous or current access to the Endo-App or other comparable digital health applications, or current active prescription
- Current participation in other clinical studies
- Failure to meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
The study explores the impact of a digital app for the self-management of (peri-)menopausal disorders. A total of 224 participants were randomized into an intervention and a control group. Findings indicate that the app offers beneficial effects on menopausal symptoms and menopause-specific quality-of-life. The study also provided valuable insights for the design of future larger trials and highlights the promising potential of the app to enhance individualized care.
- Being tested
- Menopause App
- Keywords
- Menopause, Digital Therapeutics, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menopause AppDevice
The menopause app facilitates the implementation of multimodal self-management strategies in the daily routines of individuals with a (peri-)menopausal disorder, through tools such as a symptom diary and guided interactive exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group has access to the menopause app and its functions in addition to care-as-usual Receives: Device: Menopause App |
| Control Group | No intervention | Control group has access to care-as-usual only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause-specific Quality of Life Questionnaire (MENQOL)
Menopause-specific Quality of Life Questionnaire (MENQOL): Min=1, max=8. Higher scores mean a worse outcome.
Measured: From enrollment (baseline) 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 posted23 May 2025
- Study start9 Aug 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal and Other Perimenopausal DisordersStudies 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo Health GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987617
- Sponsor's protocol ID
- RCT_PilotMeno
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 23 May 2025
- Results posted
- 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 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate the Impact of an App on the Quality of Life and Symptoms of Individuals Affected by Menopause
- ClinicalTrials.gov ID
- NCT06987617
- Acronym / sponsor ID
- RCT_PilotMeno
- Keywords
- Menopause, Digital Therapeutics, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Endo Health GmbHIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 23 May 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 study explores the impact of a digital app for the self-management of (peri-)menopausal disorders. A total of 224 participants were randomized into an intervention and a control group. Findings indicate that the app offers beneficial effects on menopausal symptoms and menopause-specific quality-of-life. The study also provided valuable insights for the design of future larger trials and highlights the promising potential of the app to enhance individualized care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Menopause AppThe intervention group has access to the menopause app and its functions in addition to care-as-usual |
| Control Group | No intervention | –Control group has access to care-as-usual only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Legal capacity
- Residency in Germany
- Female sex
- Age ≥18 years
- Known and medically confirmed (peri-)menopausal disorder (N95.1, N95.3, N95.8, N95.9)
Key exclusion criteria (5 listed)
- Changes in hormone therapy within eight weeks before the start of the study and/or planned within the next 12 weeks
- Changes in antidepressant treatment within eight weeks before the start of the study and/or planned within the next 12 weeks
- Previous or current access to the Endo-App or other comparable digital health applications, or current active prescription
- Current participation in other clinical studies
- Failure to meet the inclusion criteria
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 |
|---|---|---|
| Menopause AppThe menopause app facilitates the implementation of multimodal self-management strategies in the daily routines of individuals with a (peri-)menopausal disorder, through tools such as a symptom diary and guided interactive exercises. | Device | Intervention Group |
Primary outcome
Menopause-specific Quality of Life Questionnaire (MENQOL)
Time frame: From enrollment (baseline) to the end of treatment at 12 weeks
Menopause-specific Quality of Life Questionnaire (MENQOL): Min=1, max=8. Higher scores mean a worse outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menopause App in people with Menopausal and Other Perimenopausal Disorders, 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 12 inclusion and 5 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: finished, as of the sponsor's last update on 23 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Menopause-specific Quality of Life Questionnaire (MENQOL) (time frame: From enrollment (baseline) 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 23 May 2025.