Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT01758094
Status:
COMPLETED
Last Update Posted:
2013-01-03
First Post:
2012-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma RBP Levels in Patients With Idiopathic Hypogonadotrophic Hypogonadism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562785', 'term': 'Idiopathic Hypogonadotropic Hypogonadism'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-01', 'studyFirstSubmitDate': '2012-12-24', 'studyFirstSubmitQcDate': '2012-12-24', 'lastUpdatePostDateStruct': {'date': '2013-01-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinol binding protein 4, hs-CRP levels in patients with idiopathic hypogonadotrophic hypogonadism', 'timeFrame': '2008-2012'}], 'secondaryOutcomes': [{'measure': 'Effect of testosterone treatment on retinol binding globulin 4 and hs-CRP levels in patients with hypogodotrophic hypogonadism', 'timeFrame': '2008-2012'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hypogonadism', 'Retinol binding globulin 4', 'Testosterone treatment'], 'conditions': ['Idiopathic Hypogonadotropic Hypogonadism']}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to demonstrate the RBP4 levels, association of RBP4 with insulin resistance and influence of testosterone treatment on this cytokine in patients with idiopathic hypogonadotropic hypogonadism.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hypogonadotrophic hypogonadism', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\ndecreased serum testosterone concentration below the normal range (serum T \\< 300ng/dL), FSH and LH levels within or below the normal range, absence of a pituitary or hypothalamic mass lesions on MRI, presence of gonadotropin response to repetitive doses of GnRH, normal smell test and normal karyotypes\n\nExclusion Criteria:\n\nprevious androgen treatment, history of smoking, presence of bilateral anorchia, intellectual deficiency, diabetes mellitus, arterial hypertension or dyslipoproteinemia, medication of any kind and drug abuse. Because of possible confounding effects, patients with other hormone deficiencies were excluded.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01758094', 'briefTitle': 'Plasma RBP Levels in Patients With Idiopathic Hypogonadotrophic Hypogonadism', 'organization': {'class': 'OTHER', 'fullName': 'Gulhane School of Medicine'}, 'orgStudyIdInfo': {'id': '24122012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypogonadotropic hypogonadism patients', 'description': 'Treatment naive 25 patients with idiopathic hypogonadotrophic hypogonadism', 'interventionNames': ['Drug: Sustanon 250 mg ampule (Testosterone esters)']}], 'interventions': [{'name': 'Sustanon 250 mg ampule (Testosterone esters)', 'type': 'DRUG', 'otherNames': ['No name'], 'description': 'Drug used for treatment of hypogonadism', 'armGroupLabels': ['Hypogonadotropic hypogonadism patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06018', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gulhane School of Medicine Dep. of Endocrinology and Metabolism', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Aydogan Aydogdu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gulhane School of Medicine, Department of Endocrinology and Metabolism'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulhane School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Aydogan Aydogdu', 'investigatorAffiliation': 'Gulhane School of Medicine'}}}}