Menopausal SymptomsNCT06919887
A Randomized Controlled Trial of Menopausal Tool/App for Women
A study testing EMMII and Comparison Group in people with Menopausal Symptoms and Menopause Symptom Management, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is about assessing the utilization of a mobile phone application (app), designed to improve the menopause experience of midlife women experiencing related symptoms and its association with menopause-related health care utilization Read more about this study
- Who is it for?
- Ages 24 to 80 years
- Conditions the study is for
- Menopausal Symptoms, Menopause Symptom Management
- What is being tested?
- EMMII and Comparison Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2025to 15 Dec 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 24 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between the ages of 45 and 55
- English speaking (app only available in English)
- Able to provide informed consent
- Experiencing menopause symptoms, which will be assessed by a Menopause Rating Scale (MRS) survey score of ≥ 5
- Has an upcoming Mayo Clinic primary care appointment within 3 weeks of the enrollment and the MRS survey
Who cannot join
- Lack of willingness to engage with app
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of a Mobile Phone Application Tool for Menopause Symptom Management
The purpose of this study is about assessing the utilization of a mobile phone application (app), designed to improve the menopause experience of midlife women experiencing related symptoms and its association with menopause-related health care utilization
- Conditions
- Menopausal Symptoms, Menopause Symptom Management
- Being tested
- EMMII, Comparison Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMMIIOther
The tool/app, consists of educational components designed to enable women to more effectively identify menopause symptoms and feel confident in seeking treatment to address their symptoms. The tool/app also produces a tailored menopause discussion guide for patients to bring to their primary care appointment.
Comparison GroupOther
Receive educational menopause pamphlet describing menopause symptoms and evidence-based treatment options.
| Study group | Role | What they receive |
|---|---|---|
| The tool/app, EMMII by BettrHealth | Experimental | EMMII by BettrHealth Technology consists of educational components designed to enable women to more effectively identify menopause symptoms and feel confident in seeking treatment to address their symptoms Receives: Other: EMMII |
| Comparison Group/ Control Group | Experimental | Patients will receive the Mayo Clinic Patient Education Pamphlet MC5544 "Perimenopause \& Menopause". Receives: Other: Comparison Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of app logins among intervention group.
Measured: Up to 6 weeks
Compare differences in rates of menopause treatment among intervention and comparison groups.
Measured: Up to 6 weeks
Mean score on a validated survey assessing perceived importance and availability of healthcare services for women's health conditions/concerns related to menopause
Measured: through study completion, an average of 1 year
Percentage of healthcare professionals reporting 'high' & 'low' confidence in diagnosing and managing menopause symptoms
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start7 May 2025
- Primary completion15 May 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Menopausal SymptomsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Faubion, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919887
- Sponsor's protocol ID
- 24-013662
- Status last verified
- Jun 2026
- First submitted
- 25 Mar 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To uphold the informed consent agreements with participants, which may have specified restrictions on data sharing beyond the study team
Publications
Kling JM, French CA, Kapoor E, Hedges MS, Paul MM, Deng Y, Chaudhry R, Smith JL, Castaneda R, Cole KC, Shufelt CL, Karens A, Faubion SS. A mobile app compared with an educational pamphlet on menopause hormone therapy initiation: a randomized pilot study. Front Reprod Health. 2026 Sep 16;8:1952673. doi: 10.3389/frph.2026.1952673. eCollection 2026.
PubMed 42819486Karam J, Paul MM, Shufelt C, Ravikumar P, Fratianni AM, Oloyede S, Pagel EM, Hedges MS, Kapoor E, Kling JM, Cole K, Chaudhry R, Faubion SS. Evaluating the Efficacy of a Mobile Phone App in Enhancing Menopause Knowledge and Shared Decision-Making: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 8;14:e76536. doi: 10.2196/76536.
PubMed 41061260
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Mobile Phone Application Tool for Menopause Symptom Management
- ClinicalTrials.gov ID
- NCT06919887
- Acronym / sponsor ID
- 24-013662
- Conditions
- Menopausal Symptoms, Menopause Symptom Management
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 9 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.
The purpose of this study is about assessing the utilization of a mobile phone application (app), designed to improve the menopause experience of midlife women experiencing related symptoms and its association with menopause-related health care utilization
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The tool/app, EMMII by BettrHealth | Experimental | Other: EMMIIEMMII by BettrHealth Technology consists of educational components designed to enable women to more effectively identify menopause symptoms and feel confident in seeking treatment to address their symptoms |
| Comparison Group/ Control Group | Experimental | Other: Comparison GroupPatients will receive the Mayo Clinic Patient Education Pamphlet MC5544 "Perimenopause \& Menopause". |
Who may qualify
- Ages
- 24 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women between the ages of 45 and 55
- English speaking (app only available in English)
- Able to provide informed consent
- Experiencing menopause symptoms, which will be assessed by a Menopause Rating Scale (MRS) survey score of ≥ 5
- Has an upcoming Mayo Clinic primary care appointment within 3 weeks of the enrollment and the MRS survey
Key exclusion criteria (2 listed)
- Lack of willingness to engage with app
- Inability to provide informed consent
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 |
|---|---|---|
| EMMIIThe tool/app, consists of educational components designed to enable women to more effectively identify menopause symptoms and feel confident in seeking treatment to address their symptoms. The tool/app also produces a tailored menopause discussion guide for patients to bring to their primary care appointment. | Other | The tool/app, EMMII by BettrHealth |
| Comparison GroupReceive educational menopause pamphlet describing menopause symptoms and evidence-based treatment options. | Other | Comparison Group/ Control Group |
Primary outcome
Frequency of app logins among intervention group.
Time frame: Up to 6 weeks
Compare differences in rates of menopause treatment among intervention and comparison groups.
Time frame: Up to 6 weeks
Mean score on a validated survey assessing perceived importance and availability of healthcare services for women's health conditions/concerns related to menopause
Time frame: through study completion, an average of 1 year
Percentage of healthcare professionals reporting 'high' & 'low' confidence in diagnosing and managing menopause symptoms
Time frame: through study completion, an average of 1 year
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 16 Jun 2026.
- Derived from this study: PubMed 42819486Kling JM, French CA, Kapoor E, Hedges MS, Paul MM, Deng Y, Chaudhry R, Smith JL, Castaneda R, Cole KC, Shufelt CL, Karens A, Faubion SS. A mobile app compared with an educational pamphlet on menopause hormone therapy initiation: a randomized pilot study. Front Reprod Health. 2026 Sep 16;8:1952673. doi: 10.3389/frph.2026.1952673. eCollection 2026.
- Derived from this study: PubMed 41061260Karam J, Paul MM, Shufelt C, Ravikumar P, Fratianni AM, Oloyede S, Pagel EM, Hedges MS, Kapoor E, Kling JM, Cole K, Chaudhry R, Faubion SS. Evaluating the Efficacy of a Mobile Phone App in Enhancing Menopause Knowledge and Shared Decision-Making: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 8;14:e76536. doi: 10.2196/76536.
- Individual participant dataSharing planned: No. To uphold the informed consent agreements with participants, which may have specified restrictions on data sharing beyond the study team
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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.
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 EMMII and Comparison Group in people with Menopausal Symptoms and Menopause Symptom Management, run by Mayo Clinic at 1 site in United States.
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 5 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 16 Jun 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 United States. 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?
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?
Frequency of app logins among intervention group. (time frame: Up to 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06919887, which also lists 2 linked publications.
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 16 Jun 2026.