Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-27 @ 4:28 AM
Study NCT ID:
NCT00858650
Status:
COMPLETED
Last Update Posted:
2016-08-24
First Post:
2009-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Hypogonadism in Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005058', 'term': 'Eunuchism'}], 'ancestors': [{'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 999}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-22', 'studyFirstSubmitDate': '2009-03-09', 'studyFirstSubmitQcDate': '2009-03-09', 'lastUpdatePostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prostate Cancer', 'timeFrame': '2-years'}], 'secondaryOutcomes': [{'measure': 'PSA, IPSS, and Other Urologic Outcomes', 'timeFrame': '3-years'}, {'measure': 'Sexual Function and Hypogonadism Symptoms', 'timeFrame': '3-years'}, {'measure': 'Physical Health and Cardiovascular Outcome Measures', 'timeFrame': '3-years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['registry', 'natural history'], 'conditions': ['Male Hypogonadism', 'Androgen Deficiency', 'Testosterone Deficiency']}, 'descriptionModule': {'briefSummary': 'The primary objective of the Registry of HYpogonadism in MEn (RHYME) is to establish and maintain a large, multi-national prospective registry of male patients who have been diagnosed with male hypogonadism (HG), also known as androgen deficiency or testosterone deficiency.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hypogonadal men', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male patients aged 18 years and older.\n2. Diagnosis of hypogonadism including Klinefelter's or late onset HG. Patients may have been diagnosed at any point in their lives. Documentation of the diagnosis of HG (including symptomatology and laboratory values including testosterone levels confirmed on two separate occasions) is required.\n3. Written informed consent.\n\nExclusion Criteria:\n\n1. Any previous treatment with testosterone therapy.\n2. History of breast cancer, prostate cancer, or high-grade prostatic intraepithelial neoplasia.\n3. Prior radical prostatectomy.\n4. Life expectancy shorter than 24 months as judged by the Clinical Site investigator.\n5. Current major psychiatric disorders or drug or alcohol abuse, which will likely affect participation or compliance in the Registry, in the opinion of the Clinical Site Investigator.\n6. Gender dysphoria or sexual reassignment (e.g., transexualism).\n7. Patients actively enrolled in any interventional clinical trial.\n8. Planned relocation outside Clinical Site region within 24 months."}, 'identificationModule': {'nctId': 'NCT00858650', 'acronym': 'RHyMe', 'briefTitle': 'Registry of Hypogonadism in Men', 'organization': {'class': 'OTHER', 'fullName': 'Carelon Research'}, 'officialTitle': 'Registry of Hypogonadism in Men', 'orgStudyIdInfo': {'id': 'RHyMe'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard of Care', 'description': 'Hypogonadal males treated by standard of care, with or without testosterone replacement therapy', 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Standard of care may or may not include use of testosterone replacement therapy', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Halle', 'country': 'Germany', 'facility': 'University Hospital Halle - Center for Reproductive Medicine and Andrology', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Institute of Urology and Andrology, Segeberger Kliniken', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Private Practice of Andrology & Urology', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Herne', 'country': 'Germany', 'facility': 'Klinik fur Innere Medizin,', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'city': 'Ancona', 'country': 'Italy', 'facility': 'Ospedali Riuniti', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'Unità di Andrologia DFC AziendaOspedalieraUniversitariaCareggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Modena', 'country': 'Italy', 'facility': 'Hesperia Hospital', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Parma', 'country': 'Italy', 'facility': 'University of Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'University of Rome - Sapienza', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Amstelveen', 'country': 'Netherlands', 'facility': 'Amstelland Hospital', 'geoPoint': {'lat': 52.30083, 'lon': 4.86389}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU medical centre, department of Urology', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Arnhem', 'country': 'Netherlands', 'facility': "Andros Men's Health Institutes", 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center - Urology', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Fundacio Puigvert', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario doce de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro- Majadahonda', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Carlos Haya', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Gotenborg', 'country': 'Sweden', 'facility': 'Urohälsan i Skövde: Gotenborg University'}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital - Centre for Andrology and Sexual Medicine', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Barnsley', 'country': 'United Kingdom', 'facility': 'Barnsley Hospital', 'geoPoint': {'lat': 53.55, 'lon': -1.48333}}, {'city': 'Hampstead', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.55744, 'lon': -0.18213}}, {'city': 'Lichfield', 'country': 'United Kingdom', 'facility': 'Holly Cottage Clinic', 'geoPoint': {'lat': 52.68154, 'lon': -1.82549}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Infirmary', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Royal Victoria Infirmary', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}], 'overallOfficials': [{'name': 'Raymond Rosen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New England Research Institutes, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carelon Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}, {'name': 'Besins Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}