Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-01 @ 8:41 AM
Study NCT ID:
NCT05903404
Status:
UNKNOWN
Last Update Posted:
2023-06-15
First Post:
2023-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PCOS Indirect and Intangible Economic Burden
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], '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': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-05', 'studyFirstSubmitDate': '2023-06-05', 'studyFirstSubmitQcDate': '2023-06-05', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Information', 'timeFrame': 'One Year', 'description': 'Such as responses to survey questions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pcos', 'polycystic ovary syndrome', 'polycystic ovarian syndrome', 'stein leventhal syndrome'], 'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'The primary purpose of the PCOS Indirect and Intangible Economic Buren study is to estimate the economic costs of having PCOS in terms of quality of life and work productivity. The population will include individuals with a clinical diagnosis of PCOS, individuals self-diagnosed with PCOS, individuals with symptoms of PCOS (e.g., hirsutism, irregular menstrual cycles), and demographic-matched controls without PCOS. This study is a sub-study of The PCOS Challenge Study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population for the PCOS Indirect and Intangible Economic Burden will include individuals with a clinical diagnosis of PCOS, individuals self-diagnosed with PCOS, individuals with symptoms of PCOS (e.g., hirsutism, irregular menstrual cycles), and demographic-matched controls without PCOS.', 'genderDescription': 'Born biologically female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with PCOS by a health professional, self-diagnosed with PCOS or individuals with PCOS symptoms\n* Willing to sign the consent form\n* Able to understand the registry surveys or what is being asked\n\nExclusion Criteria:\n\n* Unable to understand the surveys or what is being asked\n* Unwilling to sign the consent form'}, 'identificationModule': {'nctId': 'NCT05903404', 'acronym': 'PCOSCHALLENGE', 'briefTitle': 'PCOS Indirect and Intangible Economic Burden', 'organization': {'class': 'OTHER', 'fullName': 'PCOS Challenge: The National Polycystic Ovary Syndrome Association'}, 'officialTitle': 'The PCOS Indirect and Intangible Economic Burden Study. A Sub-study of the PCOS Challenge Study: For the Collection of Information to Advance Research and Improve Care for PCOS Patients', 'orgStudyIdInfo': {'id': 'PCOSC002: PCOS Economic Burden'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Target Population', 'description': 'The target population includes individuals diagnosed with PCOS by a healthcare provider, self-diagnosed with PCOS, or who are exhibiting PCOS Symptoms and willing to sign the consent.'}, {'label': 'Control Population', 'description': 'The control population includes people born biologically female who have not been diagnosed with PCOS and who also do not have symptoms of PCOS.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sasha Ottey, MHA, MT (ASCP)', 'role': 'CONTACT', 'email': 'info@pcoschallenge.org', 'phone': '(404) 855-7244'}], 'facility': 'PCOS Challenge: The National Polycystic Ovary Syndrome Association', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Sasha Ottey, MHA, MT (ASCP)', 'role': 'CONTACT', 'email': 'info@pcoschallenge.org', 'phone': '(404) 855-7244'}], 'overallOfficials': [{'name': 'Sasha Ottey, MHA, MT (ASCP)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PCOS Challenge: The National Polycystic Ovary Syndrome Association'}, {'name': 'Ricardo Azziz, MD, MPH, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'Data obtained through this study may be provided to qualified researchers with academic interest in PCOS. Data or samples shared will be coded, with no PHI included.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PCOS Challenge: The National Polycystic Ovary Syndrome Association', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}