A Randomized Controlled Trial of Menopausal Tool/App for Women

Evaluation of a Mobile Phone Application Tool for Menopause Symptom Management

Status

Enrolling by invitation

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06919887

Enrollment

450

Registered

2025-04-09

Start date

2025-05-07

Completion date

2027-12-15

Last updated

2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopausal Symptoms, Menopause Symptom Management

Brief 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

Interventions

OTHEREMMII

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.

OTHERComparison Group

Receive educational menopause pamphlet describing menopause symptoms and evidence-based treatment options.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

24 Years to 80 Years

Healthy volunteers

Inclusion criteria

For Patient Enrollment: Inclusion Criteria: * 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

Exclusion criteria

* Lack of willingness to engage with app * Inability to provide informed consent

Design outcomes

Primary

Measure	Time frame
Frequency of app logins among intervention group.	Up to 6 weeks
Compare differences in rates of menopause treatment among intervention and comparison groups.	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	through study completion, an average of 1 year
Percentage of healthcare professionals reporting 'high' & 'low' confidence in diagnosing and managing menopause symptoms	through study completion, an average of 1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026