Apple Women's Health Study

• Sponsor: Apple Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04196595
• Collaborator: Harvard School of Public Health (HSPH) (Other), National Institute of Environmental Health Sciences (NIEHS) (NIH)
• Enrollment: 500,000
• Location: 1
• Anticipated Duration (Months): 119.6
• Patients Per Site Per Month: 4181

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Menstrual Cycle; Ovulation; Menstruation; Polycystic Ovary Syndrome; Infertility; Menopause; Reproduction; Reproductive Health

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Apple Women's Health Study
• Actual Study Start Date: Nov 14, 2019
• Anticipated Primary Completion Date: Nov 1, 2029
• Anticipated Study Completion Date: Nov 1, 2029

Outcome Measures

Primary Outcome Measures

1. Identify Menstrual Cycle Patterns [Up to 10 years]

   Characterized using duration of menstrual flow, and cycle length in unit of days.

2. Epidemiologic Description of Menstrual Cycle [Up to 10 years]

   Characterized using cycle patterns and self-reported demographics, no unit of measure

Secondary Outcome Measures

1. Determine prevalence of gynecologic health conditions [Up to 10 years]

   Characterized using menstrual cycle patterns and self-reported health conditions, no unit of measure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harvard T.H. Chan School of Public Health	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Apple Inc.
• Harvard School of Public Health (HSPH)
• National Institute of Environmental Health Sciences (NIEHS)

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Apple Inc.
• ClinicalTrials.gov Identifier: NCT04196595
• Other Study ID Numbers: Pro00037562
• First Posted: Dec 12, 2019
• Last Update Posted: Feb 17, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Apple Inc.: Menstruation; Menstrual Cycle; Ovulation; Polycystic Ovary Syndrome; Infertility; Menopause; Reproduction; Reproductive Health
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Infertility

Study Results

No Results Posted as of Feb 17, 2022