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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age35-55
Sponsor4YouandMe

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,250 Participants
are grouped into 4 trial groups
Group A: Main Cohort
Group B: Hormone Sub-Cohort
Group C: Bring Your Own Device (BYOD) Open Arm
Group D: Vire Clip Vasomotor Detection Sub-Cohort

Trial outcomes

Primary outcomes

1

Feasibility: Retention

Proportion of participants retained according to study protocol

Time frame
From enrollment to the end of participation at 12 months
2

Feasibility: Adherence

Mean adherence to completing in-app daily study measures

Time frame
From enrollment to the end of participation at 12 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

4YouandMe

Lead sponsor

Steven & Alexandra Cohen Foundation

Collaborator

This trial is not recruiting at the moment. You can still explore other options: