Our Transitions: Improving the Path to Menopause With Personal Digital Health Technologies

May 14, 2026 updated by: 4YouandMe
The goal of this observational study is to build knowledge about the path to menopause using subjective, self-reported and objectively measured information from multiple wearable study devices and a smartphone app. This study is being done in female individuals who are 35-55 years of age. The eventual aim of this work is two-fold; 1) to increase knowledge, awareness and education for individuals and clinicians about the lived experience of perimenopause and menopause through objectively measured data from digital study devices, and 2) to develop approaches to empower female individuals to manage this transition by learning what improves or worsens their symptoms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The ultimate objective of this research is to determine the feasibility of using multiple wearable study devices and smartphone apps to detect, track and learn how to share insights about symptoms during the path to menopause. The investigators anticipate that up to 250 participants will participate for 6 to 9 months. Participants will complete surveys and active tasks in a study app that takes on average 5 minutes a day, be provided with an Oura Ring Gen 4 and a Fitbit Sense 2 and will be expected to wear them daily. Participants will be expected to check in with a research coordinator every two weeks to go over participations and provide feedback on the wearable devices and smartphone apps. A subset of participants will be invited to participate in an at-home daily urine hormone collection for 3 menstrual cycles, measuring hormones including Luteinizing Hormone (LH), Estrone-3-glucuronide (E3G), and Pregnanediol Glucuronide (PdG). A different subset will be invited to participate in a vasomotor detection cohort using the new Vire Clip that captures core body temperature through heat flow, the dynamics of respiratory effort, and skin conductance measures at multiple layers of the skin. There will be a 'Bring Your Own Device' cohort after the main cohort enrollment is complete, where those with a personal wearable device will be invited to participate in the use of the study app for 6 to 9 months. Investigators will collect self-reported subjective symptoms and objectively measured physiological information to understand what participants learn about the use of these tools in tracking peri/menopausal symptoms. This study is done in collaboration between 4YouandMe, Women Living Better, Vector Institute, and is funded by the Steven and Alexandra Cohen Foundation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Eligible participants will live in the US or Canada. Up to 250 participants will be invited to participate in the main cohort, 75 in the hormone sub-cohort, and 70 in the Vire clip sub-cohort.

Description

Inclusion Criteria:

  • Are 35-55 years old
  • Reside in the US or Canada
  • Are able to speak, write, and read English
  • Are able to provide informed consent
  • Have a personally owned iPhone (iOS Version 16.4)

Exclusion Criteria:

  • Are not willing to wear a wearable study device
  • Have a hormonal intrauterine device (IUD)
  • Are taking birth control pills
  • Are taking systemic estrogen or progesterone
  • Have been diagnosed with Polycystic ovary syndrome (PCOS)
  • Are taking the following medications (cancer treatment that affects the menstrual cycle, thyroid medication)
  • Have had the following procedures (hysterectomy [removal of uterus], bilateral, oophorectomy [removal of both ovaries], endometrial ablation [surgery that destroys the lining of the uterus])
  • Are currently pregnant, attempting to conceive, recently pregnant and not yet cycling and currently breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Main Cohort
Up to 250 participants aged 35-55 years old, residing in the US or Canada, who will be asked to complete surveys and active tasks in a study app, and use the Oura Ring Gen 4 and Fitbit Sense 2 daily. Participants will meet with research coordinators every 2 weeks to help support participation efforts and collect information on how the study and device use are going.
Hormone Sub-Cohort
A sub-cohort of up to 75 participants will be invited to participate in a hormone sub-cohort. If the participant agrees to participate in this sub-cohort, they will be asked to complete daily at-home urine hormone samples provided to them for 3 consecutive menstrual cycles. The hormone sub-cohort procedure consists of peeing on a disposable urine test strip in the morning and then using a digital analyzer to produce the results, measuring Luteinizing Hormone (LH), Estrone-3-glucuronide (E3G), and Pregnanediol Glucuronide (PdG).
Bring Your Own Device (BYOD) Open Arm
Once enrollment is complete in the main arm, and if the participant owns their own personal wearable device that includes an Oura ring, a Garmin smartwatch, Applewatch or Fitbit, they may be able to participate in the BYOD arm where they will participate by using the study app and providing the study investigators access to their wearable data. They will be asked permission for this wearable data sharing when they first download the study app during a number of opt-in screens. Up to 1000 participants may be enrolled in the BYOD arm.
Vire Clip Vasomotor Detection Sub-Cohort
A subset of up to 70 participants will be invited to participate in a vasomotor detection cohort that will involve the use of a new wearable (Vire) clip capable of capturing core body temperature through heat flow, the dynamics of respiratory effort, and skin conductance measures at multiple layers into the skin. We want to learn whether these new wearable-derived signals could be used to detect when a vasomotor event will occur, like a hot flash, night sweat, cold sweat or feelings of sudden heating. If you meet certain eligibility criteria, you will be mailed the Vire clip and given instructions on how to set it up and sync with the study app. The Vire clip is a small clip that can be clipped onto the inside of your underwear.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility: Retention
Time Frame: From enrollment to the end of participation at 12 months
Proportion of participants retained according to study protocol
From enrollment to the end of participation at 12 months
Feasibility: Adherence
Time Frame: From enrollment to the end of participation at 12 months
Mean adherence to completing in-app daily study measures
From enrollment to the end of participation at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
4YouandMe

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Steven & Alexandra Cohen Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-OT2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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