Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-01-04 @ 9:39 PM
Study NCT ID:
NCT00593294
Status:
COMPLETED
Last Update Posted:
2008-01-15
First Post:
2008-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Contraceptive and Cardiovascular Risk in PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004997', 'term': 'Ethinyl Estradiol'}, {'id': 'D014815', 'term': 'Vitamins'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D009651', 'term': 'Norpregnatrienes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D042782', 'term': 'Estrogenic Steroids, Alkylated'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D018977', 'term': 'Micronutrients'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000078622', 'term': 'Nutrients'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-14', 'studyFirstSubmitDate': '2008-01-04', 'studyFirstSubmitQcDate': '2008-01-14', 'lastUpdatePostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcomes: Intima media thickness by carotid ultrasonography (US) and Flow Mediated Dilation by brachial artery US', 'timeFrame': 'Basal and after 3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcomes: Clinical, hormonal, and metabolic assessments', 'timeFrame': 'Basal and after 3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PCOS', 'oral contraceptives', 'physical exercise', 'CVR'], 'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '14711538', 'type': 'BACKGROUND', 'citation': 'Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004.'}]}, 'descriptionModule': {'briefSummary': 'Oral contraceptive therapy is routinely used for the treatment of menstrual disturbances of patients with polycystic ovary syndrome (PCOS).\n\nTo date, the cardiovascular risk (CVR) of the oral contraceptives (OC) are known but no data are available on the CVR in PCOS patients treated with OC or physical exercise.\n\nThe purpose of this study is to compare the effects of OC to physical exercise on the CVR of PCOS women and show the hormonal and metabolic effects of these two different treatment.\n\nWe hypothesize that physical exercise has the same beneficial effects of OC therapy on hormonal and metabolic features of PCOS women with less cardiovascular consequences.', 'detailedDescription': 'One hundred and fifty PCOS women will be enrolled. The diagnosis of PCOS was made based according to the Rotterdam criteria (1). Specifically, patients with anovulation and clinical and/or biochemical hyperandrogenism were enrolled.\n\nPatients will be randomly allocated in three groups (OC, physical exercise and placebo group) using a computer-software. Fifty PCOS patients will be treated with OC (Drospirenone 3 mg, Ethynylestradiol 30 microgram = Yasmin, Schering, Milan,Italy) other fifty PCOS will be undergone physical exercise, whereas other fifty will be treated with placebo tablets (one tablet once daily; placebo group). The duration of the treatment will be 6 months.\n\nPatients treated with OC will be instructed to follow their usual diet and physical activity, whereas patients undergone to physical exercise will be instructed to follow a detailed regular physical training program and for the diet they will be advised for the quality of food to eat. All subjects will be nonsmokers and none will drink alcoholic beverages.\n\nEach subject will undergo follow-up visits under (at three and 6 months from treatment starting) and after treatment (at three and 6 months from treatment withdrawal). At each follow-up visit, in all subjects the same operator will perform clinical, hormonal, metabolic and cardiovascular assessments by carotid and brachial artery US'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Polycystic ovary syndrome\n\nExclusion Criteria:\n\n* Age \\<18 or \\>40 years\n* BMI higher than 30 and lower than 18\n* Pregnancy\n* Hypothyroidism, hyperprolactinemia, Cushing's syndrome, nonclassical congenital adrenal hyperplasia, use of OC, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic or antiobesity drugs or other hormonal drugs within the previous 6 months\n* Subjects with neoplastic, metabolic (including glucose intolerance), hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, or malabsorptive disorders, cephalea)"}, 'identificationModule': {'nctId': 'NCT00593294', 'briefTitle': 'Oral Contraceptive and Cardiovascular Risk in PCOS', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Comparison of Oral Contraceptive Versus Physical Exercise Effects on Cardiovascular and Metabolic Risk Factors in PCOS Women', 'orgStudyIdInfo': {'id': '2007-12-2871'}, 'secondaryIdInfos': [{'id': 'CE209/07'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A,1,I', 'interventionNames': ['Behavioral: Physical exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B, 2, II', 'interventionNames': ['Drug: OC - Drospirenone plus Ethynylestradiol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C,3,III', 'interventionNames': ['Dietary Supplement: Vitamin, polyvitamins tablets']}], 'interventions': [{'name': 'Physical exercise', 'type': 'BEHAVIORAL', 'description': '45 minutes each day for three times/week for 6 months', 'armGroupLabels': ['A,1,I']}, {'name': 'OC - Drospirenone plus Ethynylestradiol', 'type': 'DRUG', 'description': '1 cp for 21 days each month for 6 months of OC (Drospirenone 3 mg plus Ethynylestradiol 30 microgram = Yasmin, Schering, Milan, Italy)', 'armGroupLabels': ['B, 2, II']}, {'name': 'Vitamin, polyvitamins tablets', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Tablet of vitamin 1cp for 21 days each month for 6 months', 'armGroupLabels': ['C,3,III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'state': 'Naples', 'country': 'Italy', 'facility': 'Department of Molecular and Clinical Endocrinology and Oncology, University "Federico II"', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Francesco Orio, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy'}, {'name': 'Gaetano Lombardi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy'}, {'name': 'Stefano Palomba, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chair of Obstetrics and Gynecology, University "Magna Graecia" Catanzaro, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Francesco Orio', 'oldOrganization': 'Dpt of Mol and Clin Endocrinology and Oncology Federico II University of Naples'}}}}