Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-01-29 @ 4:54 PM
Study NCT ID:
NCT04196595
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2019-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apple Women's Health Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2029-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2019-11-13', 'studyFirstSubmitQcDate': '2019-12-10', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify Menstrual Cycle Patterns', 'timeFrame': 'Up to 10 years', 'description': 'Characterized using duration of menstrual flow, and cycle length in unit of days.'}, {'measure': 'Epidemiologic Description of Menstrual Cycle', 'timeFrame': 'Up to 10 years', 'description': 'Characterized using cycle patterns and self-reported demographics, no unit of measure'}], 'secondaryOutcomes': [{'measure': 'Determine prevalence of gynecologic health conditions', 'timeFrame': 'Up to 10 years', 'description': 'Characterized using menstrual cycle patterns and self-reported health conditions, no unit of measure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Menstruation', 'Menstrual Cycle', 'Ovulation', 'Polycystic Ovary Syndrome', 'Infertility', 'Menopause', 'Reproduction', 'Reproductive Health'], 'conditions': ['Menstrual Cycle', 'Ovulation', 'Menstruation', 'Polycystic Ovary Syndrome', 'Infertility', 'Menopause', 'Reproduction', 'Reproductive Health']}, 'referencesModule': {'references': [{'pmid': '36414993', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Convenience sampling of individuals who have ever menstruated and meet other eligibility criteria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have menstruated at least once\n* Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico)\n* Live in the United States of America\n* Be comfortable communicating in written and spoken English\n* Have installed the Apple Research app on your iPhone\n* Not share your iCloud account or iPhone with anyone else\n* Be willing and able to provide informed consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT04196595', 'briefTitle': "Apple Women's Health Study", 'organization': {'class': 'INDUSTRY', 'fullName': 'Apple Inc.'}, 'officialTitle': "Apple Women's Health Study", 'orgStudyIdInfo': {'id': 'Pro00037562'}}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shruthi Mahalingaiah', 'role': 'CONTACT', 'email': 'AppleWomensHealthStudy@hsph.harvard.edu', 'phone': '617-432-1356'}], 'facility': 'Harvard T.H. Chan School of Public Health', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Shruthi Mahalingaiah, MD', 'role': 'CONTACT', 'email': 'AppleWomensHealthStudy@hsph.harvard.edu', 'phone': '617-432-1356'}], 'overallOfficials': [{'name': 'Michelle A Williams, SM, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}, {'name': 'Russ B Hauser, MD, MPH, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}, {'name': 'Brent A Coull, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}, {'name': 'Shruthi Mahalingaiah, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apple Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, {'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}