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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Feasibility: Retention
Proportion of participants retained according to study protocol
Feasibility: Adherence
Mean adherence to completing in-app daily study measures
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: