NCT04196595

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500,000

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Nov 2019Nov 2029

First Submitted

Initial submission to the registry

November 13, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

November 14, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

10 years

First QC Date

November 13, 2019

Last Update Submit

July 1, 2024

Conditions

Keywords

MenstruationMenstrual CycleOvulationPolycystic Ovary SyndromeInfertilityMenopauseReproductionReproductive Health

Outcome Measures

Primary Outcomes (2)

  • Identify Menstrual Cycle Patterns

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

    Up to 10 years

  • Epidemiologic Description of Menstrual Cycle

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

    Up to 10 years

Secondary Outcomes (1)

  • Determine prevalence of gynecologic health conditions

    Up to 10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard T.H. Chan School of Public Health

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (1)

  • Zhang 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.

MeSH Terms

Conditions

Polycystic Ovary SyndromeInfertility

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2019

First Posted

December 12, 2019

Study Start

November 14, 2019

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2029

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations