Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
Study NCT ID:
NCT01940666
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2013-04-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Presentations of Hyperandrogenic Phenotypes in Taiwanese Women
Sponsor:
Organization:
Raw JSON
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SUMMARY ANSWER: Subjects with excess free androgen index tend to be obese and face the highest metabolic syndrome risk, adipocytokine alterations, insulin resistance (IR) and cardiovascular risk. The excess TT group presents with a marginal IR risk, while the excess A4 group has the highest antimüllerian hormone (AMH), and may counterbalance obesity; this group and the excess DHEA-S group have a favorable association with IR.', 'detailedDescription': 'STUDY DESIGN, SIZE, DURATION:A retrospective study in 160 Taiwanese women with HA and 165 women without HA, with medical records reviewed from 2009 up to 2012. The hyperandrogenic women were classified into four groups (TT, A4, FAI, and DHEA-S) according to independent abnormally elevated androgen measures each above its cut-off value, and the groups were compared with each other and with controls.\n\nPARTICIPANTS/MATERIALS, SETTING, METHODS: This study was performed in the Reproductive Endocrinology Clinic at Wan Fang Medical Center in Taipei, Taiwan. Anthropometric, metabolic, endocrine, and IR components as well as lipid accumulation product (LAP) index were compared between the groups. IR was assessed with the following markers: fasting glucose and insulin levels, oral glucose tolerance test, glucose-to-insulin ratio and homeostasis model assessment of IR index (HOMA-IR).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '48 Years', 'minimumAge': '13 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A retrospective review of the medical records of women who visited the Reproductive Endocrinology Clinic was carried out at the Wan Fang Medical Center at Taipei Medical University from 2009 and up to 2012. A total of 160 Taiwanese women with hyperandrogenism (HA) and 165 women without hyperandrogenism (non-HA) were included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Hyperandrogenic women who were classified into four groups:\n\n * Total testosterone (TT),\n * Androstenedione (A4),\n * Free androgen index (FAI),\n * and Dehydroepiandrosterone sulphate(DHEA-S).\n* According to abnormally elevated androgen measures each above its cut-off value, and non hyperandrogenic women (who had all androgens below their cut-off values)\n\nExclusion Criteria:\n\n* None of the women studied had\n\n * Hypogonadotropic hypogondism,\n * Hyperprolactinemia,\n * Congenital adrenal hyperplasia,\n * Premature ovarian failure,\n * Androgen-secreting tumors,\n * Cushing's syndrome,\n * or any other endocrine or systemic disease that may affect the reproductive function,\n * or any disorders of the uterus (e.g. Asherman's syndrome and Mullerian genesis) and chromosomal anomalies (e.g. Turner's syndrome).\n* In addition, we excluded females who had\n\n * Experienced menarche less than three years preceding the study start,\n * or who had day 3 FSH \\> 15 mIU/ml, as well as women with insufficient clinical/biochemical records,\n * and women with ovarian cysts or tumors in an ultrasonographic examination."}, 'identificationModule': {'nctId': 'NCT01940666', 'briefTitle': 'Presentations of Hyperandrogenic Phenotypes in Taiwanese Women', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'officialTitle': 'Clinical and Biochemical Presentations of Distinctive Types of Biochemical Hyperandrogenism in Premenopausal Taiwanese Women', 'orgStudyIdInfo': {'id': 'WFH-TMU-PCOS-201207025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Controls', 'description': 'patients who have all androgens (TT, A4, FAI, and DHEA-S) lower than their cut-off values'}, {'label': 'Total Testosterone >= 2.39', 'description': 'Patients who have only total testosterone higher than its cut-off value; (TT) \\>=2.39'}, {'label': 'Androstenedione >= 2.99', 'description': 'Patients who have only androstenedione higher than its cut-off value; (A4) \\>=2.99'}, {'label': 'Free Androgen Index >= 6.53', 'description': 'Patients who have only free androgen index higher than its cut-off value; (FAI) \\>=6.53'}, {'label': 'DHEAs >= 181.55', 'description': 'Patients who have only dehyroepiandrosterone sulfate higher than its cut-off value; (DHEA-S)\\>=181.55'}]}, 'contactsLocationsModule': {'locations': [{'zip': '116', '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': 'WanFang Medical Center at Taipei Medical University'}]}, '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': '2013-11-21', 'type': 'RELEASE'}, {'date': '2014-01-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ming-I Hsu, MD, Taipei Medical University WanFang Hospital, Taipei Medical University WanFang Hospital'}}}}