N95.1 Menopausal and Female Climacteric StatesEMMANCT07663305
Evaluation of a Mobile Menopause Application
A study testing Menopause App in people with N95.1 Menopausal and Female Climacteric States, run by Endo Health GmbH at 1 site in Germany.
Trial summary
This study examines whether a digital app can help women manage symptoms of menopause. A total of 426 women with medically confirmed menopausal symptoms are randomly assigned to either use the app in addition to their usual medical care for 24 weeks, or to continue with usual care alone. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- N95.1 Menopausal and Female Climacteric States
- 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
- 426 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jul 2026to Aug 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Legal capacity
- Ability to provide informed consent
- Residency in Germany
- Female gender
- Age ≥18 years
- Medically confirmed menopausal or other perimenopausal disorder (N95.1)
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- Ownership of a smartphone and ability to use it
- 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
- MRS II ≥ 9
- Absence of exclusion criteria
Who cannot join
- Pregnancy or breastfeeding during the study period
- Current hormonal replacement therapy (HRT), initiation of HRT within eight weeks prior to study start and/or planned start of HRT during the study period
- Changes in treatment with psychotropic medication within eight weeks prior to study start and/or planned during the study period
- Start of psychotherapy within eight weeks prior to study start and/or planned during the study period
- Start of a rehabilitation program within eight weeks prior to study start and/or planned during the study period
- Surgery performed within eight weeks prior to study start and/or planned during the study period
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- 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. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Medicoles
Hanover
Elisabeth Siegmund-Schultze, Dr. med., studienleitung@wechseljahr-studie.de
Elisabeth Siegmund-Schultze, Dr. med.
About this study
This study examines whether a digital app can help women manage symptoms of menopause. A total of 426 women with medically confirmed menopausal symptoms are randomly assigned to either use the app in addition to their usual medical care for 24 weeks, or to continue with usual care alone. The app provides evidence-based content and exercises for multimodal menopause management. Participants are followed up over 24 weeks, with the primary outcome assessed at 12 weeks. The main goal is to evaluate whether the app improves menopause-specific quality of life.
- 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 menopausal disorder, through tools such as a symptom diary and guided interactive exercises.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group has access to care-as-usual only. |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause-specific quality of life
Assessed with the Menopause-specific Quality of Life Questionnaire (MENQOL)
Measured: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Secondary outcomes (4)
Menopause-specific symptom severity
Assessed with the Menopause Rating Scale (MRS II)
Measured: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Daily interference due to hot flashes
Assessed with the Hot Flash Related Daily Interference Scale (HFRDIS)
Measured: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Menopause-specific impairment in daily activities
Assessed with the Activity Impairment domain of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause)
Measured: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Patient activation
Assessed with the Patient Activation Measure 13 (PAM-13)
Measured: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start6 Jul 2026
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for N95.1 Menopausal and Female Climacteric StatesStudies 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
- Randomization will be stratified by the presence of concomitant treatment (non-hormonal concomitant treatment vs no concomitant treatment at baseline) to ensure balanced allocation across this prognostic factor.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 426 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
- NCT07663305
- Sponsor's protocol ID
- RCT_EMMA
- Acronym
- EMMA
- Status last verified
- Sep 2026
- First submitted
- 17 Jun 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Mobile Menopause Application
- ClinicalTrials.gov ID
- NCT07663305
- Acronym / sponsor ID
- EMMA / RCT_EMMA
- Keywords
- Menopause, Digital Therapeutics, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 426 participants (estimated)
- Lead sponsor
- Endo Health GmbHIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 23 Jun 2026 (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 examines whether a digital app can help women manage symptoms of menopause. A total of 426 women with medically confirmed menopausal symptoms are randomly assigned to either use the app in addition to their usual medical care for 24 weeks, or to continue with usual care alone. The app provides evidence-based content and exercises for multimodal menopause management. Participants are followed up over 24 weeks, with the primary outcome assessed at 12 weeks. The main goal is to evaluate whether the app improves menopause-specific quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Randomization will be stratified by the presence of concomitant treatment (non-hormonal concomitant treatment vs no concomitant treatment at baseline) to ensure balanced allocation across this prognostic factor.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group has access to care-as-usual only. |
| Intervention Group | Experimental | Device: Menopause AppThe intervention group has access to the menopause app and its functions in addition to care-as-usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Legal capacity
- Ability to provide informed consent
- Residency in Germany
- Female gender
- Age ≥18 years
Key exclusion criteria (9 listed)
- Pregnancy or breastfeeding during the study period
- Current hormonal replacement therapy (HRT), initiation of HRT within eight weeks prior to study start and/or planned start of HRT during the study period
- Changes in treatment with psychotropic medication within eight weeks prior to study start and/or planned during the study period
- Start of psychotherapy within eight weeks prior to study start and/or planned during the study period
- Start of a rehabilitation program within eight weeks prior to study start and/or planned during the study period
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 menopausal disorder, through tools such as a symptom diary and guided interactive exercises. | Device | Intervention Group |
Primary outcome
Menopause-specific quality of life
Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Assessed with the Menopause-specific Quality of Life Questionnaire (MENQOL)
4 secondary outcomes
Menopause-specific symptom severity
Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Daily interference due to hot flashes
Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Menopause-specific impairment in daily activities
Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Patient activation
Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
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 2 Oct 2026.
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 Menopause App in people with N95.1 Menopausal and Female Climacteric States, 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 14 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopause-specific quality of life (time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)). 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 2 Oct 2026.