Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-21 @ 6:08 PM
Study NCT ID:
NCT01644305
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2012-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma Levels of GDF-9 and GDF-15 in Patients With Polycystic Ovary Syndrome.
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_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-26', 'studyFirstSubmitDate': '2012-07-17', 'studyFirstSubmitQcDate': '2012-07-18', 'lastUpdatePostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The association of GDF 9 AND GDF 15 with bone and cardiovascular parameters in women with polycystic ovary syndrome', 'timeFrame': '1 year'}]}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '24430093', 'type': 'DERIVED', 'citation': 'Berberoglu Z, Aktas A, Fidan Y, Yazici AC, Aral Y. Association of plasma GDF-9 or GDF-15 levels with bone parameters in polycystic ovary syndrome. J Bone Miner Metab. 2015 Jan;33(1):101-8. doi: 10.1007/s00774-013-0560-8. Epub 2014 Jan 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the plasma levels of GDF-9 and GDF-15, and their association with bone and cardiovascular parameters in patients with Polycystic Ovary Syndrome.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital Endocrinology Outpatient Clinic', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients at ages 25-35 diagnosed with polycystic ovarian syndrome and idiopathic hirsutism\n\nExclusion Criteria:\n\n* acute infectious disease, a thyroid, pituitary, nutritional, inflammatory, hepatic, renal, or neoplastic disorder; history of cardiovascular disease or pulmonary embolism; a family history of coronary artery disease; smoking history; hypertension; diabetes mellitus; use of oral contraceptives, anti-androgens and drugs known to interfere with cytokine release, such as corticosteroids, immunosuppressors, or nonsteroidal antiinflammatory drugs.\n\nany medication known to affect hormonal or metabolic parameters.'}, 'identificationModule': {'nctId': 'NCT01644305', 'briefTitle': 'Plasma Levels of GDF-9 and GDF-15 in Patients With Polycystic Ovary Syndrome.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ankara Education and Research Hospital'}, 'officialTitle': '1. Association of Plasma GDF-9 or GDF-15 Levels With Bone Parameters in Polycystic Ovary Syndrome. 2. Plasma GDF-15 Levels and Their Association With Hormonal and Metabolic Status in Women With Polycystic Ovary Syndrome Aged 25-35.', 'orgStudyIdInfo': {'id': '3849'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Polycystic Ovary Syndrome'}, {'label': 'Idiopathic hirsutism'}, {'label': 'Control'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06340', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Education and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass. Prof.', 'investigatorFullName': 'Zehra Berberoglu', 'investigatorAffiliation': 'Ankara Education and Research Hospital'}}}}