Menstrual CycleNCT04196595
Apple Women's Health Study
An observational study of Menstrual Cycle and Ovulation, run by Apple Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle, Ovulation, Menstruation
- How many people
- 500,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2019to Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Convenience sampling of individuals who have ever menstruated and meet other eligibility criteria
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Harvard T.H. Chan School of Public Health
Boston, Massachusetts, 02115
Shruthi Mahalingaiah, 617-432-1356, AppleWomensHealthStudy@hsph.harvard.edu
About this study
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.
- Conditions
- Menstrual Cycle, Ovulation, Menstruation, Polycystic Ovary Syndrome, Infertility, Menopause
- Keywords
- Menstruation, Menstrual Cycle, Ovulation, Polycystic Ovary Syndrome, Infertility, Menopause, Reproduction, Reproductive Health
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify Menstrual Cycle Patterns
Characterized using duration of menstrual flow, and cycle length in unit of days.
Measured: Up to 10 years
Epidemiologic Description of Menstrual Cycle
Characterized using cycle patterns and self-reported demographics, no unit of measure
Measured: Up to 10 years
Secondary outcomes (1)
Determine prevalence of gynecologic health conditions
Characterized using menstrual cycle patterns and self-reported health conditions, no unit of measure
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start14 Nov 2019
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apple Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Harvard School of Public Health (HSPH), National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor
- Investigators
- Michelle A Williams, SM, ScD, Principal investigator, Harvard School of Public Health (HSPH)Russ B Hauser, MD, MPH, ScD, Principal investigator, Harvard School of Public Health (HSPH)Brent A Coull, PhD, Principal investigator, Harvard School of Public Health (HSPH)Shruthi Mahalingaiah, MD, MS, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196595
- Sponsor's protocol ID
- Pro00037562
- Status last verified
- Jul 2024
- First submitted
- 13 Nov 2019
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang Z, Peebles E, Baird DD, Jukic AMZ, Wilcox AJ, Curry CL, Fischer-Colbrie T, Onnela JP, Williams MA, Hauser R, Coull BA, Mahalingaiah S. Menstrual product use patterns in a large digital cohort in the United States: variations by sociodemographic, health, and menstrual characteristics. Am J Obstet Gynecol. 2025 Sep;233(3):184.e1-184.e15. doi: 10.1016/j.ajog.2025.03.002. Epub 2025 Mar 10.
PubMed 40073916Zhang CY, Li H, Zhang S, Suharwardy S, Chaturvedi U, Fischer-Colbrie T, Maratta LA, Onnela JP, Coull BA, Hauser R, Williams MA, Baird DD, Jukic AMZ, Mahalingaiah S, Curry CL. Abnormal uterine bleeding patterns determined through menstrual tracking among participants in the Apple Women's Health Study. Am J Obstet Gynecol. 2023 Feb;228(2):213.e1-213.e22. doi: 10.1016/j.ajog.2022.10.029. Epub 2022 Oct 29.
PubMed 36414993
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apple Women's Health Study
- ClinicalTrials.gov ID
- NCT04196595
- Acronym / sponsor ID
- Pro00037562
- Conditions
- Menstrual Cycle, Ovulation, Menstruation, Polycystic Ovary Syndrome, Infertility, Menopause
- Keywords
- Menstruation, Menstrual Cycle, Ovulation, Polycystic Ovary Syndrome, Infertility, Menopause, Reproduction, Reproductive Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500,000 participants (estimated)
- Lead sponsor
- Apple Inc.Industry (pharma, biotech, devices)
- Collaborators
- Harvard School of Public Health (HSPH), National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Convenience sampling of individuals who have ever menstruated and meet other eligibility criteria
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify Menstrual Cycle Patterns
Time frame: Up to 10 years
Characterized using duration of menstrual flow, and cycle length in unit of days.
Epidemiologic Description of Menstrual Cycle
Time frame: Up to 10 years
Characterized using cycle patterns and self-reported demographics, no unit of measure
1 secondary outcome
Determine prevalence of gynecologic health conditions
Time frame: Up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 40073916Wang Z, Peebles E, Baird DD, Jukic AMZ, Wilcox AJ, Curry CL, Fischer-Colbrie T, Onnela JP, Williams MA, Hauser R, Coull BA, Mahalingaiah S. Menstrual product use patterns in a large digital cohort in the United States: variations by sociodemographic, health, and menstrual characteristics. Am J Obstet Gynecol. 2025 Sep;233(3):184.e1-184.e15. doi: 10.1016/j.ajog.2025.03.002. Epub 2025 Mar 10.
- Derived from this study: PubMed 36414993Zhang CY, Li H, Zhang S, Suharwardy S, Chaturvedi U, Fischer-Colbrie T, Maratta LA, Onnela JP, Coull BA, Hauser R, Williams MA, Baird DD, Jukic AMZ, Mahalingaiah S, Curry CL. Abnormal uterine bleeding patterns determined through menstrual tracking among participants in the Apple Women's Health Study. Am J Obstet Gynecol. 2023 Feb;228(2):213.e1-213.e22. doi: 10.1016/j.ajog.2022.10.029. Epub 2022 Oct 29.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle A Williams, SM, ScD principal investigator
Harvard School of Public Health (HSPH)
Russ B Hauser, MD, MPH, ScD principal investigator
Harvard School of Public Health (HSPH)
Brent A Coull, PhD principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Cycle and Ovulation, run by Apple Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shruthi Mahalingaiah, MD (617-432-1356, AppleWomensHealthStudy@hsph.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify Menstrual Cycle Patterns (time frame: Up to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04196595, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.