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Apple Women's Health Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04196595
Recruitment Status : Recruiting
First Posted : December 12, 2019
Last Update Posted : February 17, 2022
Sponsor:
Collaborators:
Harvard School of Public Health (HSPH)
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Apple Inc.

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
Menstrual Cycle Ovulation Menstruation Polycystic Ovary Syndrome Infertility Menopause Reproduction Reproductive Health

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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Identify Menstrual Cycle Patterns [ Time Frame: Up to 10 years ]
    Characterized using duration of menstrual flow, and cycle length in unit of days.

  2. Epidemiologic Description of Menstrual Cycle [ Time Frame: 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 [ Time Frame: Up to 10 years ]
    Characterized using menstrual cycle patterns and self-reported health conditions, no unit of measure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Convenience sampling of individuals who have ever menstruated and meet other eligibility criteria
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04196595


Contacts
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Contact: Shruthi Mahalingaiah, MD 617-432-1356 AppleWomensHealthStudy@hsph.harvard.edu

Locations
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United States, Massachusetts
Harvard T.H. Chan School of Public Health Recruiting
Boston, Massachusetts, United States, 02115
Contact: Shruthi Mahalingaiah    617-432-1356    AppleWomensHealthStudy@hsph.harvard.edu   
Sponsors and Collaborators
Apple Inc.
Harvard School of Public Health (HSPH)
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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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)
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Responsible Party: Apple Inc.
ClinicalTrials.gov Identifier: NCT04196595    
Other Study ID Numbers: Pro00037562
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Polycystic Ovary Syndrome
Infertility
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases