Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-03-10 @ 11:32 PM
Study NCT ID:
NCT03313635
Status:
COMPLETED
Last Update Posted:
2018-07-13
First Post:
2017-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Prealbumin Levels in Men With Low-T
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Frozen serum samples are retained for this study and possible future studies.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-11', 'studyFirstSubmitDate': '2017-10-13', 'studyFirstSubmitQcDate': '2017-10-13', 'lastUpdatePostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prealbumin Levels', 'timeFrame': '1 day', 'description': 'Evaluation of prealbumin levels in subjects presenting for evaluation of possible late onset adult hypogonadism diagnosed with and without Androgen Deficiency (AD)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Prealbumin'], 'conditions': ['Testosterone Deficiency']}, 'descriptionModule': {'briefSummary': 'This is a single-center study intended to evaluate prealbumin (transthyretin), a marker of anabolic metabolism, in men with androgen deficiency (Low-T). There is emerging evidence that prealbumin is an indicator of anabolic, versus catabolic, metabolism, and that lower levels may be associated with hypogonadism.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men between the ages of 40 and 75 presenting with signs/symptoms of low-T.', 'genderDescription': 'Male sex at birth', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide responses to standard questionnaires administered to subjects\n* Written Informed Consent obtained\n* Male sex at birth\n* ≥ 40 and ≤ 75 years of age\n* Presentation to the clinic with symptoms suggestive of low testosterone such as loss of libido, erectile dysfunction, cognitive or mood disturbances, etc.\n* Able and willing to provide blood specimens and follow study schedule\n* A final diagnosis can be established (androgen deficient versus not androgen deficient)\n\nExclusion Criteria:\n\n* Previous exposure to exogenous T, DHEA, clomiphen citrate, or other Selective Estrogen Receptor Modulators, or OTC or herbals (Treatment Naïve)\n* Use of opioid medication within 3 months prior to enrollment\n* Serious psychiatric disease or uncontrolled medical illness, as suspected from medical history or clinical examination\n* Use of any sex hormones or steroidal anabolic drug supplements (OTC or prescribed)(Treatment Naïve)\n* Incapable of giving informed consent or complying with protocol or unwilling to comply with protocol requirements\n* Diagnosis of prolactinoma'}, 'identificationModule': {'nctId': 'NCT03313635', 'briefTitle': 'Evaluation of Prealbumin Levels in Men With Low-T', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beckman Coulter, Inc.'}, 'officialTitle': 'Prealbumin (Transthyretin) Levels in Men With Low-T', 'orgStudyIdInfo': {'id': 'AND-1-17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Men presenting with low-T', 'description': 'Men presenting with low-t will undergo a blood draw for evaluation of prealbumin levels.', 'interventionNames': ['Diagnostic Test: Men presenting with low-T']}], 'interventions': [{'name': 'Men presenting with low-T', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluation of prealbumin levels.', 'armGroupLabels': ['Men presenting with low-T']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02467', 'city': 'Chestnut Hill', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Men's Health Boston", 'geoPoint': {'lat': 42.33065, 'lon': -71.16616}}], 'overallOfficials': [{'name': 'Abraham Morgentaler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Men's Health Boston"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beckman Coulter, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}