Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-27 @ 11:19 PM
Study NCT ID:
NCT02111434
Status:
COMPLETED
Last Update Posted:
2014-04-14
First Post:
2014-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism and Effect of Testosteron Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-10', 'studyFirstSubmitDate': '2014-04-05', 'studyFirstSubmitQcDate': '2014-04-09', 'lastUpdatePostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to change of visceral adiposity index with testosteron replacement', 'timeFrame': 'baseline and 6 months'}, {'measure': 'time to change of TG/HDL cholesterol ratio with testosteron replacement', 'timeFrame': 'baseline and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['visceral adiposity index', 'triglycerides / hdl cholesterol ratio', 'testosterone'], 'conditions': ['Hypogonadism']}, 'descriptionModule': {'briefSummary': 'The study is designed to answer the following questions:\n\n1. What is the levels of visceral adiposity index and Triglycerides/HDL cholesterol ratio in hypogonadism?\n2. What is the effect of testosterone replacement on the visceral adiposity index and Triglycerides/HDL cholesterol ratio?', 'detailedDescription': 'This is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2007-2010.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men\n* Congenital hypogonadism\n* Treatment Naive\n\nExclusion Criteria:\n\n* Previous history of androgen replacement\n* Hypertension\n* Diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT02111434', 'briefTitle': 'Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism and Effect of Testosteron Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Gulhane School of Medicine'}, 'officialTitle': 'Phase 4 Study of Effect of Testosteron Treatment on the Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism', 'orgStudyIdInfo': {'id': 'GSM-022014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'testosterone', 'description': 'testosterone gel per day for 6 months testosterone 250 mg injection per 3-4 weeks for 6 months', 'interventionNames': ['Drug: Testosterone']}], 'interventions': [{'name': 'Testosterone', 'type': 'DRUG', 'otherNames': ['sustanon 250 mg'], 'description': 'Testosterone 250 mg injection per 3-4 weeks for 6 months', 'armGroupLabels': ['testosterone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06018', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gulhane School of Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulhane School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'cem haymana', 'investigatorAffiliation': 'Gulhane School of Medicine'}}}}