Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:46 AM
Study NCT ID:
NCT01148433
Status:
COMPLETED
Last Update Posted:
2011-12-22
First Post:
2010-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Life With TESTIM®
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-21', 'studyFirstSubmitDate': '2010-06-21', 'studyFirstSubmitQcDate': '2010-06-21', 'lastUpdatePostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Testosterone Level', 'timeFrame': '6 months', 'description': 'Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6)'}], 'secondaryOutcomes': [{'measure': 'Quality of Life - (determined by the MFI questionnaire)', 'timeFrame': '6 months', 'description': 'Determined at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6)'}, {'measure': 'Multidimensional Fatigue Inventory (MFI) - (based on 20 questions regarding QoL)', 'timeFrame': '6 months', 'description': 'Used at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6)'}, {'measure': 'Loss of Libido - (determined by the International Index of Erectile Function (IIEF-5)', 'timeFrame': '6 months', 'description': 'Used at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6)'}, {'measure': 'Aging Male Scale (AMS) - (17 questions regarding the discomfort associated with testosterone deficiency)', 'timeFrame': '6 months', 'description': 'Used at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6)'}, {'measure': 'Laboratory Parameters: PSA and Haematocrit levels', 'timeFrame': '6 months', 'description': 'Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypogonadism']}, 'descriptionModule': {'briefSummary': 'The present non-interventional study is to document the testosterone levels in patients with clinical symptoms such as loss of sexual desire indicating hypogonadism (testosterone deficiency syndrome). During testosterone replacement therapy with TESTIM®, the changes in the quality of life - especially with respect to motivation, activity and fatigue - of hypogonadal patients will be documented and correlated with the testosterone levels during the course of therapy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Private practices', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* therapeutic need according to SPC\n* written informed consent\n\nExclusion Criteria:\n\n* contraindications according to SPC'}, 'identificationModule': {'nctId': 'NCT01148433', 'acronym': 'LIFE', 'briefTitle': 'Quality of Life With TESTIM®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'Quality of Life With TESTIM® in Testosterone Replacement Therapy for Male Patients With Hypogonadism', 'orgStudyIdInfo': {'id': 'FE999303 CS01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TESTIM® - drug given by prescription', 'description': 'Male patients with Hypogonadism'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Apolda', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 51.02624, 'lon': 11.51638}}, {'city': 'Aschersleben', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 51.75742, 'lon': 11.46084}}, {'city': 'Bad Bergzaben', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 49.10245, 'lon': 8.00092}}, {'city': 'Bad Schönborn', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 49.20122, 'lon': 8.64179}}, {'city': 'Bautzen', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 51.18035, 'lon': 14.43494}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigational Site, Helene-Weigel-Platz 10', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigational Site, Kurfürstendamm 33', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigational Site, Königin-Elisabeth-Straße 1', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigational Site, Tempelhofer Damm 227', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigational Site, Turmstraße 82', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigational Site, Wilmersdorfer Straße 62', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bielefeld', 'country': 'Germany', 'facility': 'Investigational site', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'city': 'Bramsche', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 52.40881, 'lon': 7.97288}}, {'city': 'Braunschweig', 'country': 'Germany', 'facility': 'Investigational Site, Humboldtstraße 4', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'city': 'Braunschweig', 'country': 'Germany', 'facility': 'Investigational site, Ritterbrunen 7', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'city': 'Bremerhaven', 'country': 'Germany', 'facility': 'Investigational Site, Dr.-Franz-Mertens-Straße 8', 'geoPoint': {'lat': 53.55357, 'lon': 8.57553}}, {'city': 'Bremerhaven', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 53.55357, 'lon': 8.57553}}, {'city': 'Büdingen', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 50.29013, 'lon': 9.1114}}, {'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Investigational Site, Carl-von-Ossietzky-Straße 151', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Investigational Site, Clausstraße 44', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Investigational Site, Unritzstraße 21 c', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Dortmund', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'city': 'Dossenheim', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 49.45028, 'lon': 8.67472}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Forchheim', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 49.71754, 'lon': 11.05877}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Investigational Site, Eschersheimer Landstr. 544', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Investigational Site, Im Steinbügel 13', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Freiberg', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 50.91089, 'lon': 13.33881}}, {'city': 'Fulda', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 50.55162, 'lon': 9.67518}}, {'city': 'Gera', 'country': 'Germany', 'facility': 'Investigational site', 'geoPoint': {'lat': 50.88029, 'lon': 12.08187}}, {'city': 'Greifswald', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'city': 'Halle', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Investigational Site, Neuenfelder Straße 96', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Investigational Site, Sand 35', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Investigational Site, Schweriner Straße 25', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Investigational Site, Tangstedter Landstraße 77', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Heilbronn', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 49.13995, 'lon': 9.22054}}, {'city': 'Henningsdorf', 'country': 'Germany', 'facility': 'Investigational Site'}, {'city': 'Hermsdorf', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 52.61421, 'lon': 13.30587}}, {'city': 'Kamenz', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 51.26798, 'lon': 14.09374}}, {'city': 'Kulmbach', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 50.10068, 'lon': 11.45032}}, {'city': 'Landsberg/Lech', 'country': 'Germany', 'facility': 'Investigational Site'}, {'city': 'Langenfeld', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 51.10821, 'lon': 6.94831}}, {'city': 'Lübeck', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Mühlhausen', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 51.20896, 'lon': 10.45275}}, {'city': 'München', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Neustadt', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 53.55196, 'lon': 9.98558}}, {'city': 'Nordhorn', 'country': 'Germany', 'facility': 'Investigational Site, Am Museumsturm 4', 'geoPoint': {'lat': 52.43081, 'lon': 7.06833}}, {'city': 'Nordhorn', 'country': 'Germany', 'facility': 'Investigational Site, Osnabrücker Str. 1', 'geoPoint': {'lat': 52.43081, 'lon': 7.06833}}, {'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'city': 'Offenbach', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 50.10061, 'lon': 8.76647}}, {'city': 'Paderborn', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 51.71905, 'lon': 8.75439}}, {'city': 'Pulheim', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 50.99965, 'lon': 6.80632}}, {'city': 'Ribnitz-Damgarten', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 54.2422, 'lon': 12.45666}}, {'city': 'Rostock', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'city': 'Rottweil', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 48.16783, 'lon': 8.62719}}, {'city': 'Rüttenscheid', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 51.43607, 'lon': 7.00569}}, {'city': 'Schwerte', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 51.44387, 'lon': 7.5675}}, {'city': 'Tostedt', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 53.28333, 'lon': 9.71667}}, {'city': 'Tönisvorst', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 51.32092, 'lon': 6.49412}}, {'city': 'Weinheim', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 49.54887, 'lon': 8.66697}}, {'city': 'Wilhelmshaven', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 53.5476, 'lon': 8.10395}}, {'city': 'Wolfsburg', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 52.42452, 'lon': 10.7815}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ferring Arzneimittel GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}