Viewing Study NCT01350895


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Study NCT ID: NCT01350895
Status: COMPLETED
Last Update Posted: 2013-11-06
First Post: 2011-05-09
Is Possible Gene Therapy: False
Has Adverse Events: False

Brief Title: Clinical and Biochemical Presentation of Polycystic Ovary Syndrome in Different Age Group
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-12-24', 'releaseDate': '2013-11-06'}, {'resetDate': '2014-02-14', 'releaseDate': '2013-12-30'}, {'resetDate': '2014-12-17', 'releaseDate': '2014-12-09'}, {'resetDate': '2016-01-12', 'releaseDate': '2015-12-08'}], 'estimatedResultsFirstSubmitDate': '2013-11-06'}}, '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': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 781}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-04', 'studyFirstSubmitDate': '2011-05-09', 'studyFirstSubmitQcDate': '2011-05-09', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Polycystic ovarian syndrome (PCOS)'], 'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'To study the clinical and biochemical characteristics women with polycystic ovary syndrome (PCOS) in different aged groups.', 'detailedDescription': 'Polycystic ovarian syndrome (PCOS) is the most frequent endocrine disorder of reproductive age women, affecting an estimated 9-18% of all women in this age group. To diagnose of PCOS in early life is especially important because it is now thought to increase metabolic and cardiovascular risks. Investigating PCOS is crucial as it is now considered to increase metabolic and cardiovascular risk, thereby impacting the health of women to a much greater extent than previously thought. We are plan using retrospective analysis to evaluate the clinical and biochemical presentation of PCOS in different aged groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '46 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Reproductive age women', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Reproductive age women with sufficient data\n\nExclusion Criteria:\n\n* Disorders of uterus (e.g. Asherman's Syndrome, Mullerian agenesis) and chromosomal anomalies (e.g. Turner syndrome)\n* women who had had menarche at less than 3 years of age, Day 3 FSH \\> 15, or who were older than 46\n* women with inadequate clinical/biochemical records\n* and women who had had ovarian cysts or ovarian tumors in ultrasonography examination\n* pregnancy women"}, 'identificationModule': {'nctId': 'NCT01350895', 'briefTitle': 'Clinical and Biochemical Presentation of Polycystic Ovary Syndrome in Different Age Group', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'officialTitle': 'Clinical and Biochemical Presentation of Polycystic Ovary Syndrome in Different Age Group', 'orgStudyIdInfo': {'id': 'WFH-PCOS-100002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental Group'}, {'label': 'Control Group'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University-WanFang Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ming-I Hsu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University WanFang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Doctor', 'investigatorFullName': 'Ming-I Hsu', 'investigatorAffiliation': 'Taipei Medical University WanFang Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-11-06', 'type': 'RELEASE'}, {'date': '2013-12-24', 'type': 'RESET'}, {'date': '2013-12-30', 'type': 'RELEASE'}, {'date': '2014-02-14', 'type': 'RESET'}, {'date': '2014-12-09', 'type': 'RELEASE'}, {'date': '2014-12-17', 'type': 'RESET'}, {'date': '2015-12-08', 'type': 'RELEASE'}, {'date': '2016-01-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ming-I Hsu, MD, Attending Doctor, Taipei Medical University WanFang Hospital'}}}}