Apple Women's Health Study

July 20, 2023 updated by: Apple Inc.
This is an observational longitudinal study to advance the understanding of menstrual cycle and gynecologic health conditions including PCOS, infertility and breast cancer.The study will be hosted within the Research app(available on App Store), which allows a user to find, enroll, and participate in Apple-supported health-related research studies.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500000

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 Locations

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Convenience sampling of individuals who have ever menstruated and meet other eligibility criteria

Description

Inclusion Criteria:

  • Have menstruated at least once
  • Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico)
  • Live in the United States of America
  • Be comfortable communicating in written and spoken English
  • Have installed the Apple Research app on your iPhone
  • Not share your iCloud account or iPhone with anyone else
  • Be willing and able to provide informed consent to participate in the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify Menstrual Cycle Patterns
Time Frame: Up to 10 years
Characterized using duration of menstrual flow, and cycle length in unit of days.
Up to 10 years
Epidemiologic Description of Menstrual Cycle
Time Frame: Up to 10 years
Characterized using cycle patterns and self-reported demographics, no unit of measure
Up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine prevalence of gynecologic health conditions
Time Frame: Up to 10 years
Characterized using menstrual cycle patterns and self-reported health conditions, no unit of measure
Up to 10 years

Collaborators and Investigators

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

Sponsor

Apple Inc.

Collaborators

National Institute of Environmental Health Sciences (NIEHS)
Harvard School of Public Health (HSPH)

Investigators

  • Principal Investigator: Michelle A Williams, SM, ScD, Harvard School of Public Health (HSPH)
  • Principal Investigator: Russ B Hauser, MD, MPH, ScD, Harvard School of Public Health (HSPH)
  • Principal Investigator: Brent A Coull, PhD, Harvard School of Public Health (HSPH)
  • Principal Investigator: Shruthi Mahalingaiah, MD, MS, Harvard School of Public Health (HSPH)

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 (Actual)

November 14, 2019

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00037562

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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