Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-01-11 @ 10:41 PM
Study NCT ID:
NCT01909505
Status:
UNKNOWN
Last Update Posted:
2013-07-26
First Post:
2013-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Salivary and Serum Free Testosterone in Normal and Hypogonadal Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-24', 'studyFirstSubmitDate': '2013-07-24', 'studyFirstSubmitQcDate': '2013-07-24', 'lastUpdatePostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood and saliva testosterone', 'timeFrame': '1 year', 'description': 'Measures of blood and saliva testosterone'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Known Androgen Deficiency']}, 'descriptionModule': {'briefSummary': 'Low testosterone is a common male problem. The diagnosis of low testosterone often requires blood sampling and expensive testing. We want to know if measuring saliva testosterone can be used in place of blood sampling. Study participants will be asked to provide samples of blood and saliva for the measurement of testosterone. These results may lead to the development of a saliva test for testosterone.', 'detailedDescription': 'Testosterone is required for normal male health that is known to decline in aging or other conditions. Physiologically active testosterone, also known as "free" testosterone, is present as a small percentage of the total blood level, mostly bound to sex hormone binding globulin and albumin. Estimation of serum free testosterone is difficult and costly, requiring equilibrium dialysis of a serum sample. These binding proteins are not normally present in saliva. It is hypothesized that the free fraction of testosterone in blood is in equilibrium with the extravascular space, notably saliva. The sponsor proposes to test this hypothesis by sampling saliva and serum and measuring testosterone. Serum free testosterone will be measured following equilibrium dialysis. To perform this study approximately 40 eugonadal and 20 hypogonadal males will be recruited.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Forty normal males and 20 male subjects, 25 to 65 years of age.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal male subjects aged 20-65 years\n\nExclusion Criteria:\n\n* Women Smokers, HIV positive, diabetes, hepatatis C positive, subjects currently taking testosterone who are unwilling to suspend use for teh duration of the trial, subjects taking aldactone or medicines that may interfere with the protocol'}, 'identificationModule': {'nctId': 'NCT01909505', 'briefTitle': 'Comparison of Salivary and Serum Free Testosterone in Normal and Hypogonadal Men', 'organization': {'class': 'INDUSTRY', 'fullName': 'Saliva Biomarkers, Inc.'}, 'officialTitle': 'Comparison of Salivary Testosterone With Serum Free Testosterone Done by Equilibrium Dialysis.', 'orgStudyIdInfo': {'id': 'Saliva Testosterone'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal Males', 'description': 'Males with normal levels of serum testosterone'}, {'label': 'Hypogonadal males', 'description': 'Males known to have low levels of serum testosterone'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amber Surian', 'role': 'CONTACT', 'email': 'aas64@georgetown.edu', 'phone': '202-444-1210'}, {'name': 'West T Moore, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '21827', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ernest Evans', 'role': 'CONTACT', 'email': 'eevans21@jhmi.edu', 'phone': '410-955-2812'}, {'name': 'Adrian Dobbs, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "John's Hopkins University Medical Center", 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'West T Moore, M.D.', 'role': 'CONTACT', 'email': 'mooret@jhmi.edu', 'phone': '410 967 7395'}], 'overallOfficials': [{'name': 'West T Moore, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgetown University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saliva Biomarkers, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}