Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
Study NCT ID:
NCT00410306
Status:
COMPLETED
Last Update Posted:
2010-09-24
First Post:
2006-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bosnia and Herzegovina', 'China']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010792', 'term': 'testosterone undecanoate'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1493}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-23', 'studyFirstSubmitDate': '2006-12-11', 'studyFirstSubmitQcDate': '2006-12-11', 'lastUpdatePostDateStruct': {'date': '2010-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events, adverse drug reactions, patient reported tolerability', 'timeFrame': 'during 4 injection intervals'}], 'secondaryOutcomes': [{'measure': 'Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observation', 'timeFrame': 'after 4 injection intervals'}, {'measure': 'Change in subjective assessment of the patient (overall sexual desire/libido, vigor/vitality, mood, ability to concentrate) from baseline to end of observation', 'timeFrame': 'after 4 injection intervals'}, {'measure': 'Change in intensity of symptoms or disorders associated with low testosterone (hot flushes or excessive sweating, sleep disturbances, decreased physical strength and erectile dysfunction) from baseline to end of observation', 'timeFrame': 'after 4 injection intervals'}, {'measure': 'Patient reported outcome at end of observation (satisfaction with current androgen therapy, comparison to previous androgen therapy, if applicable)', 'timeFrame': 'after 4 injection intervals'}, {'measure': 'Treatment continuation rate', 'timeFrame': 'after 4 injection intervals'}, {'measure': 'Vital signs and anthropometric measurements (Blood pressure, heart rate, weight and waist circumference)', 'timeFrame': 'during 4 injection intervals'}, {'measure': 'Laboratory values (PSA, hemoglobin, hematocrit, HbA1C, T-chol, HDL-chol, LDL-chol, triglycerides)', 'timeFrame': 'during 4 injection intervals'}, {'measure': 'Digital rectal examination', 'timeFrame': 'during 4 injection intervals'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypogonadism', 'Nebido', 'Testosterone', 'Observational Study'], 'conditions': ['Male', 'Hypogonadism']}, 'descriptionModule': {'briefSummary': 'This is an observational study with a drug called Nebido, a new testosterone replacement therapy, which is available for the treatment of male hypogonadism. The benefit and safety of Nebido have already been thoroughly evaluated through well controlled clinical trials. The main purpose of this observational study is to confirm the established safety profile of Nebido in daily clinical practice.', 'detailedDescription': 'The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from routine practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male hypogonadal patients eligible for long-term testosterone therapy who have newly been prescribed Nebido® in accordance with the terms of the marketing authorization\n\nExclusion Criteria:\n\n* Patients presenting with contraindications as stated in the product information'}, 'identificationModule': {'nctId': 'NCT00410306', 'acronym': 'IPASS Nebido', 'briefTitle': 'Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'International, Multi-center Post Authorization Surveillance Study on the Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice (IPASS Nebido)', 'orgStudyIdInfo': {'id': '14203'}, 'secondaryIdInfos': [{'id': '2005/00888'}, {'id': 'MP-04199'}, {'id': 'NE0601'}, {'id': '39732'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Testosterone Undecanoate (Nebido, BAY86-5037)']}], 'interventions': [{'name': 'Testosterone Undecanoate (Nebido, BAY86-5037)', 'type': 'DRUG', 'description': 'Patients from routine practice', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Australia'}, {'city': 'Many Locations', 'country': 'Austria'}, {'city': 'Many Locations', 'country': 'Bulgaria'}, {'city': 'Many Locations', 'country': 'Colombia'}, {'city': 'Many Locations', 'country': 'Czechia'}, {'city': 'Many Locations', 'country': 'Estonia'}, {'city': 'Many Locations', 'country': 'Germany'}, {'city': 'Many Locations', 'country': 'Hong Kong'}, {'city': 'Many Locations', 'country': 'Indonesia'}, {'city': 'Many Locations', 'country': 'Italy'}, {'city': 'Many Locations', 'country': 'Jordan'}, {'city': 'Many Locations', 'country': 'Kazakhstan'}, {'city': 'Many Locations', 'country': 'Latvia'}, {'city': 'Many Locations', 'country': 'Lebanon'}, {'city': 'Many Locations', 'country': 'Lithuania'}, {'city': 'Many Locations', 'country': 'Malaysia'}, {'city': 'Many Locations', 'country': 'Malta'}, {'city': 'Many Locations', 'country': 'Mexico'}, {'city': 'Many Locations', 'country': 'Moldova'}, {'city': 'Many Locations', 'country': 'North Macedonia'}, {'city': 'Many Locations', 'country': 'Philippines'}, {'city': 'Many Locations', 'country': 'Romania'}, {'city': 'Many Locations', 'country': 'Russia'}, {'city': 'Many Locations', 'country': 'Saudi Arabia'}, {'city': 'Many Locations', 'country': 'Singapore'}, {'city': 'Many Locations', 'country': 'Slovenia'}, {'city': 'Many Locations', 'country': 'South Korea'}, {'city': 'Many Locations', 'country': 'Spain'}, {'city': 'Many Locations', 'country': 'Taiwan'}, {'city': 'Many Locations', 'country': 'Thailand'}, {'city': 'Many Locations', 'country': 'Turkey (Türkiye)'}, {'city': 'Many Locations', 'country': 'Ukraine'}, {'city': 'Many Locations', 'country': 'United Kingdom'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Therapeutic Area Head', 'oldOrganization': 'Bayer Schering Pharma AG'}}}}