Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT01538602
Status:
COMPLETED
Last Update Posted:
2012-02-24
First Post:
2012-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mean Platelet Volume and TXA2 Levels in Patients With Polycystic Ovary Syndrome (PCOS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], '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': 'CASE_ONLY'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'lastUpdateSubmitDate': '2012-02-23', 'studyFirstSubmitDate': '2012-02-21', 'studyFirstSubmitQcDate': '2012-02-23', 'lastUpdatePostDateStruct': {'date': '2012-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean platelet volume'}, {'measure': 'Thromboxane A2'}]}, 'conditionsModule': {'keywords': ['PCOS', 'cardiovascular disorders'], 'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'Polycystic ovary syndrome (PCOS)is closely associated with insulin resistance and hyperinsulinemia as well as with increased incidence in diabetes, hypertension, dyslipidemia and atherosclerosis. Indeed, subjects with PCOS were reported to carry an increased long-term cardiovascular risk, among others. Aiming to correlate the mean platelet volume, the thromboxane A2 level and the PCOS, an observational study was planned. Clinical evaluation of metabolic outcomes in PCOS patients is compared to a placebo group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Volunteers', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women fulfilled two out of three diagnostic criteria for PCOS\n\nExclusion Criteria:\n\n* Pre-existing secondary endocrine disorders\n* History of hypertension, diabetes mellitus or cardiovascular disorders\n* Pharmacologic treatment in the last 6 months before entering the study.'}, 'identificationModule': {'nctId': 'NCT01538602', 'briefTitle': 'Mean Platelet Volume and TXA2 Levels in Patients With Polycystic Ovary Syndrome (PCOS)', 'organization': {'class': 'OTHER', 'fullName': 'AGUNCO Obstetrics and Gynecology Centre'}, 'orgStudyIdInfo': {'id': 'MPV_PCOS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PCOS patients'}, {'label': 'Healthy volunteers'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Catania', 'country': 'Italy', 'facility': 'Istituto di Patologia Ostetrica e Ginecologica', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AGUNCO Obstetrics and Gynecology Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}