EMMII App for Menopause

Overseen By Sey V Oloyede

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Lack of app engagement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

450 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the EMMII treatment for menopause?

The research suggests a growing trend towards using lifestyle modifications and complementary therapies for managing menopause symptoms, which may support the effectiveness of the EMMII treatment if it incorporates these elements. ^{1 2 3 4 5}

Is the EMMII App for Menopause safe for humans?

The research articles provided do not contain specific safety data for the EMMII App for Menopause or its related treatments under different names. ^{6 7 8 9 10}

How does the EMMII App for Menopause differ from other treatments for menopause?

The EMMII App for Menopause is unique because it uses a digital platform to help women track and manage their menopause symptoms, offering a convenient and accessible alternative to traditional treatments. Unlike medications, this app focuses on symptom tracking and management through technology, which may appeal to those seeking non-pharmaceutical options. ^{2 7 11 12 13}

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for English-speaking women aged 45-55 who are experiencing menopause symptoms, as indicated by a Menopause Rating Scale score of ≥5. Participants must be able to consent and have an upcoming primary care appointment at Mayo Clinic within 3 weeks of enrollment.

Inclusion Criteria

I am a woman aged between 45 and 55.

I speak English.

Able to provide informed consent

Exclusion Criteria

Inability to provide informed consent

I am not willing to use an app for the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the EMMII app or receive educational pamphlets to manage menopause symptoms

8 weeks

Follow-up

Participants are monitored for changes in menopause-related health care utilization and symptom management effectiveness

4 weeks

Treatment Details

Interventions

• Comparison Group
• EMMII

Trial Overview The study is evaluating the effectiveness of a mobile app called EMMII designed to improve the menopause experience compared to a control group without the app. It will also look at how using this app affects health care use related to menopause.

Participant Groups

Group I: The tool/app, EMMII by BettrHealth Experimental Treatment 1 Intervention

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

Group II: Comparison Group/ Control Group Experimental Treatment 1 Intervention

Patients will receive the Mayo Clinic Patient Education Pamphlet MC5544 "Perimenopause \& Menopause".

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

In a study involving 1,242 postmenopausal women treated with ospemifene 60 mg/day for up to 52 weeks, there was no increase in endometrial cancer or hyperplasia, indicating strong endometrial safety.

The mean increase in endometrial thickness was minimal (0.81 mm at 12 months) compared to the placebo group (0.07 mm), further supporting the safety profile of ospemifene for treating vulvar and vaginal atrophy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endometrial safety of ospemifene: results of the phase 2/3 clinical development program. Constantine, GD., Goldstein, SR., Archer, DF.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Determination of menopausal status in women: the NHLBI-sponsored Women's Ischemia Syndrome Evaluation (WISE) Study. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility of an iPad application for studying menopause-related symptom clusters and women's heuristics. [2017]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Complementary and hormonal therapy for vasomotor symptom relief: a conservative clinical approach. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Web-based interventions for menopause: A systematic integrated literature review. [2018]

5. Ireland pubmed.ncbi.nlm.nih.gov

A systematic review of menopausal symptom management decision aid trials. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Critical evaluation of the safety of Cimicifuga racemosa in menopause symptom relief. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Dose-Dependent Effects of the Cimicifuga racemosa Extract Ze 450 in the Treatment of Climacteric Complaints: A Randomized, Placebo-Controlled Study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Endometrial safety of ospemifene: results of the phase 2/3 clinical development program. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Ospemifene's effect on vasomotor symptoms: a post hoc analysis of phase 2 and 3 clinical data. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Ospemifene for the treatment of menopausal vaginal dryness, a symptom of the genitourinary syndrome of menopause. [2020]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Enhancing Women's Health: An Assessment of Data Privacy and Security of Menopause FemTech Applications. [2023]

12. Ireland pubmed.ncbi.nlm.nih.gov

An evaluation of demographic characteristics and workplace experiences of UK employees using an employer-provided menopause application. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Undertreatment of menopausal symptoms and novel options for comprehensive management. [2018]