Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-31 @ 9:55 AM
Study NCT ID:
NCT01604603
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2012-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical and Biochemical Characteristics in Women With Different Menstrual Pattern
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-01-07', 'releaseDate': '2013-11-19'}], 'estimatedResultsFirstSubmitDate': '2013-11-19'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 470}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-04', 'studyFirstSubmitDate': '2012-05-21', 'studyFirstSubmitQcDate': '2012-05-22', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Regular Menstrual Cycle', 'Irregular Menstrual Cycle']}, 'descriptionModule': {'briefSummary': 'Background: Menstrual disturbance is the major complain in reproductive age women, the clinical and biochemical characteristics of women with different menstrual disturbance had not been well-understood. Objective: To study the clinical and biochemical characteristics of women with oligomenorrhea, amenorrhea, and premature ovarian failure. Method: Retrospective study, medical records reviewed in patients who visited to outpatient clinic of Reproductive Medicine in Taipei Medical University - Wan Fang Hospital form 2009 Jan. 1 to 2011 Nov. 31. Including criteria: Patients had sufficient medical records (anthropometric, endocrine, metabolic, lipid parameters) and age less than 45. Excluding criteria: (1) Women who experienced menarche \\<3 years before the beginning of the study; (2) Women who received hormones or drugs for major medical diseases; (3) Women who presented ovarian cysts or ovarian tumors, uterine abnormality; (4) Women who were \\>45 years old.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '13 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients had sufficient medical records (anthropometric, endocrine, metabolic, lipid parameters) and age less than 45.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients had sufficient medical records (anthropometric, endocrine, metabolic, lipid parameters) and age less than 45.\n\nExclusion Criteria:\n\n1. Women who experienced menarche \\<3 years before the beginning of the study;\n2. Women who received hormones or drugs for major medical diseases;\n3. Women who presented ovarian cysts or ovarian tumors, uterine abnormality;\n4. Women who were \\>45 years old.'}, 'identificationModule': {'nctId': 'NCT01604603', 'briefTitle': 'The Clinical and Biochemical Characteristics in Women With Different Menstrual Pattern', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'orgStudyIdInfo': {'id': 'WFH-TMU-RetroMcLab-201203022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control'}, {'label': 'Oligomenorrhea'}, {'label': 'Amenorrhea'}, {'label': 'premature ovarian failure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110', 'city': 'Taipei', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'WanFang Medical Center at Taipei Medical University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ming I Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University WanFang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Taipei Medical University WanFang Hospital', 'investigatorFullName': 'Ming-I Hsu', 'investigatorAffiliation': 'Taipei Medical University WanFang Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-11-19', 'type': 'RELEASE'}, {'date': '2014-01-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ming-I Hsu, MD, Taipei Medical University WanFang Hospital, Taipei Medical University WanFang Hospital'}}}}