Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT02467751
Status:
UNKNOWN
Last Update Posted:
2017-03-20
First Post:
2015-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Women 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'}], '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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-17', 'studyFirstSubmitDate': '2015-03-25', 'studyFirstSubmitQcDate': '2015-06-07', 'lastUpdatePostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic profile', 'timeFrame': '12 months', 'description': 'total cholesterol (mg/dL) and fractions, triglycerides (mg/dL) will estimate'}], 'secondaryOutcomes': [{'measure': 'Classical glycemic index', 'timeFrame': '12 months', 'description': 'Classical glycemic index (mg/dL) will estimate'}, {'measure': 'Liver function', 'timeFrame': '12 months', 'description': 'Liver function (U/L) will estimate'}, {'measure': 'luteinizing hormone', 'timeFrame': '12 months', 'description': 'luteinizing hormone (IU/L) will estimate'}, {'measure': 'Hormonal profile - insulin', 'timeFrame': '12 months', 'description': 'Hormonal profile - insulin (uIU/ml) will estimate'}, {'measure': 'Follicle stimulating hormone', 'timeFrame': '12 months', 'description': 'Follicle stimulating hormone (IU/L) will estimate'}, {'measure': 'thyreostimulating hormone', 'timeFrame': '12 months', 'description': 'thyreostimulating hormone (uIU/ML) will estimate'}, {'measure': 'Total and free testosterone', 'timeFrame': '12 months', 'description': 'Total and free testosterone (ng/ml) will estimate'}, {'measure': '17-hydroxyprogesterone', 'timeFrame': '12 months', 'description': '17-hydroxyprogesterone (ng/ml) will estimate'}, {'measure': 'Dehydroepiandrosterone', 'timeFrame': '12 months', 'description': 'Dehydroepiandrosterone (ng/ml) will estimate'}, {'measure': 'Prolactin', 'timeFrame': '12 months', 'description': 'Prolactin (ug/ml) will estimate'}, {'measure': 'DEXA', 'timeFrame': '12 months', 'description': 'Body composition will measure by DEXA scan'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '37909624', 'type': 'DERIVED', 'citation': 'Macruz CF, Lima SMRR. Polycystic ovary syndrome and abdominal fat: is there a relationship? Rev Assoc Med Bras (1992). 2023 Oct 27;69(11):e20230874. doi: 10.1590/1806-9282.20230874. eCollection 2023.'}, {'pmid': '28099715', 'type': 'DERIVED', 'citation': 'Macruz CF, Lima SM, Salles JE, da Silva GM, Scalissi NM. Assessment of the body composition of patients with polycystic ovary syndrome using dual-energy X-ray absorptiometry. Int J Gynaecol Obstet. 2017 Mar;136(3):285-289. doi: 10.1002/ijgo.12066. Epub 2017 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'Metabolic profile in women of different body composition with polycystic ovary syndrome.', 'detailedDescription': 'Will be performed case-control study with women with Polycystic Ovary Syndrome, according to the Rotterdam criteria and body mass index between 18 to 29.9. The control group will consist of women without Polycystic Ovary Syndrome, with a body mass index of 18 to 29.9 and no other comorbidities. In both groups collect anthropometric data such as age, weight, height, waist circumference and blood pressure. Exams will be requested: metabolic profile (total cholesterol (mg/dL) and fractions, triglycerides (mg/dL), blood count, liver function (U/L) and classical glycemic index (mg/dL); hormonal profile - insulin (uIU/ml), luteinizing hormone (IU/L), follicle stimulating hormone (IU/L), thyreostimulating hormone (uIU/ML), total and free testosterone (ng/ml), 17-hydroxyprogesterone (ng/ml), dehydroepiandrosterone (ng/ml), prolactin (ug/ml). Body composition (BMI) will be performed by absorption technique of two low energy beams emitted by X-ray - full body densitometry (DEXA). Expected result: To evaluate visceral fat and truncal of patients with diagnosis of Polycystic Ovary Syndrome without obesity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '39 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Will be performed case-control study with women with Polycystic Ovary Syndrome, according to the Rotterdam criteria and body mass index between 18 to 29.9. The control group will consist of women without Polycystic Ovary Syndrome, with a body mass index of 18 to 29.9 and no other comorbidities.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Polycystic Ovary Syndrome , body mass index of 18 to 29.9, without contraceptive use.\n\nExclusion Criteria:\n\n* Hypothyroidism, hyperprolactinaemia (defined as serum prolactin levels greater than 25 ng/mL)\n* Cushing's syndrome\n* Nonclassical congenital adrenal hyperplasia (defined as serum 17-hydroxyprogesterone levels greater than 1.2 and 5.2 ng/mL in the follicular and luteal phase, respectively) and current or previous (within the last three months) use of oral contraceptives and other hormonal\n* Antidiabetic and antiobesity drugs."}, 'identificationModule': {'nctId': 'NCT02467751', 'acronym': 'PCOS', 'briefTitle': 'Women With Polycystic Ovary Syndrome (PCOS)', 'organization': {'class': 'OTHER', 'fullName': 'Irmandade da Santa Casa de Misericordia de Sao Paulo'}, 'officialTitle': 'Metabolic Profile in Women of Different Body Composition With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': '167/10'}}, 'contactsLocationsModule': {'locations': [{'zip': '01225001', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Carolina Macruz', 'role': 'CONTACT', 'email': 'carolmacruz@gmail.com', 'phone': '+5511999141447'}], 'facility': 'Carolina Furtado Macruz', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Carolina F Macruz, doctor', 'role': 'CONTACT', 'email': 'carolmacruz@gmail.com', 'phone': '+5511999141447', 'phoneExt': 'Brazil'}, {'name': 'Irmandade Santa Casa Sao Paulo', 'role': 'CONTACT', 'phone': '+551121767385', 'phoneExt': 'Brazil'}], 'overallOfficials': [{'name': 'Carolina Macruz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Irmandade Santa Casa de Misericordia Sao Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'When I have finished my recruitment and analysis of the results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Irmandade da Santa Casa de Misericordia de Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Carolina Furtado Macruz', 'investigatorAffiliation': 'Irmandade da Santa Casa de Misericordia de Sao Paulo'}}}}