Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-29 @ 1:14 AM
Study NCT ID:
NCT01150903
Status:
COMPLETED
Last Update Posted:
2021-07-19
First Post:
2010-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'As it was a retrospective study and no safety data (adverse events and serious adverse events) were analyzed, hence number of participants affected and at risk were reported as 0.', 'eventGroups': [{'id': 'EG000', 'title': 'Index PDE5i Prescription', 'description': 'Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control (Without PDE5i Prescription)', 'description': 'Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24708', 'groupId': 'OG000'}, {'value': '74124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Index PDE5i Prescription', 'description': 'Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).'}, {'id': 'OG001', 'title': 'Control (Without PDE5i Prescription)', 'description': 'Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).'}], 'classes': [{'categories': [{'measurements': [{'value': '70.23', 'groupId': 'OG000'}, {'value': '55.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Chi-square test was used to calculate p-value.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day -92 up to Day -1 of index prescription', 'description': 'Underlying conditions were defined as any diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population) and age-matched participants without any PDE5i prescription during the study period (control population). Last observation carried forward method was used.'}, {'type': 'PRIMARY', 'title': 'Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24708', 'groupId': 'OG000'}, {'value': '74124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Index PDE5i Prescription', 'description': 'Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).'}, {'id': 'OG001', 'title': 'Control (Without PDE5i Prescription)', 'description': 'Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.53', 'groupId': 'OG000'}, {'value': '7.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Chi-square test was used to calculate p-value.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to Day 91 post index prescription', 'description': 'New diagnosis of underlying condition at prescription was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population) and age-matched participants without any PDE5i prescription during the study period (control population). Last observation carried forward method was used.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24708', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Index PDE5i Prescription', 'description': 'Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.08', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day -92 up to Day -1 of index prescription', 'description': 'New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24708', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Index PDE5i Prescription', 'description': 'Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.65', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 366 up to Day 457 post index prescription', 'description': 'New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '892', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Index PDE5i Prescription', 'description': 'Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).'}], 'classes': [{'categories': [{'measurements': [{'value': '67.49', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years (Early study period - January 1999 to December 2001)', 'description': 'Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '892', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Index PDE5i Prescription', 'description': 'Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.32', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years (Early study period - January 1999 to December 2001)', 'description': 'New diagnosis of underlying condition at PDE5i market introduction was defined as any new diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9862', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Index PDE5i Prescription', 'description': 'Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).'}], 'classes': [{'categories': [{'measurements': [{'value': '72.14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years (End of study period - July 2006 to June 2008)', 'description': 'Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9862', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Index PDE5i Prescription', 'description': 'Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.06', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years (End of study period - July 2006 to June 2008)', 'description': 'New diagnosis of underlying condition at PDE5i establishment was defined as any new diagnosis of interest between day 0 (index prescription) and day 91 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two-years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Index PDE5i Prescription', 'description': 'Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).'}, {'id': 'FG001', 'title': 'Control (Without PDE5i Prescription)', 'description': 'Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24708'}, {'groupId': 'FG001', 'numSubjects': '74124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24708'}, {'groupId': 'FG001', 'numSubjects': '74124'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24708', 'groupId': 'BG000'}, {'value': '74124', 'groupId': 'BG001'}, {'value': '98832', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Index PDE5i Prescription', 'description': 'Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).'}, {'id': 'BG001', 'title': 'Control (Without PDE5i Prescription)', 'description': 'Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.63', 'spread': '11.59', 'groupId': 'BG000'}, {'value': '57.63', 'spread': '11.59', 'groupId': 'BG001'}, {'value': '57.63', 'spread': '11.59', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.0', 'groupId': 'BG000', 'lowerLimit': '18.0', 'upperLimit': '91.0'}, {'value': '59.0', 'groupId': 'BG001', 'lowerLimit': '18.0', 'upperLimit': '91.0'}, {'value': '59.0', 'groupId': 'BG002', 'lowerLimit': '18.0', 'upperLimit': '91.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24708', 'groupId': 'BG000'}, {'value': '74124', 'groupId': 'BG001'}, {'value': '98832', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98832}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-15', 'studyFirstSubmitDate': '2010-06-24', 'resultsFirstSubmitDate': '2012-04-03', 'studyFirstSubmitQcDate': '2010-06-24', 'lastUpdatePostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-04-03', 'studyFirstPostDateStruct': {'date': '2010-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription', 'timeFrame': 'Day -92 up to Day -1 of index prescription', 'description': 'Underlying conditions were defined as any diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.'}, {'measure': 'Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91', 'timeFrame': 'Day 0 to Day 91 post index prescription', 'description': 'New diagnosis of underlying condition at prescription was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.'}, {'measure': 'Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription', 'timeFrame': 'Day -92 up to Day -1 of index prescription', 'description': 'New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.'}, {'measure': 'Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription', 'timeFrame': 'Day 366 up to Day 457 post index prescription', 'description': 'New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.'}, {'measure': 'Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period', 'timeFrame': 'Up to 3 years (Early study period - January 1999 to December 2001)', 'description': 'Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period', 'timeFrame': 'Up to 3 years (Early study period - January 1999 to December 2001)', 'description': 'New diagnosis of underlying condition at PDE5i market introduction was defined as any new diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.'}, {'measure': 'Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period', 'timeFrame': 'Up to 2 years (End of study period - July 2006 to June 2008)', 'description': 'Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.'}, {'measure': 'Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period', 'timeFrame': 'Up to 2 years (End of study period - July 2006 to June 2008)', 'description': 'New diagnosis of underlying condition at PDE5i establishment was defined as any new diagnosis of interest between day 0 (index prescription) and day 91 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two-years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['erectile dysfunction', 'phosphodiesterase inhibitor', 'cardiovascular diseases'], 'conditions': ['Erectile Dysfunction', 'Cardiovascular Diseases', 'Male Urogenital Diseases']}, 'referencesModule': {'references': [{'pmid': '21676121', 'type': 'DERIVED', 'citation': 'Kirby MG, Schnetzler G, Zou KH, Symonds T. Prevalence and detection rate of underlying disease in men with erectile dysfunction receiving phosphodiesterase type 5 inhibitors in the United Kingdom: a retrospective database study. Int J Clin Pract. 2011 Jul;65(7):797-806. doi: 10.1111/j.1742-1241.2011.02693.x.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481287&StudyName=Identification%20of%20underlying%20conditions%20in%20men%20prescribed%20a%20PDE5%20inhibitor%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Erectile dysfunction (ED) has been identified as an independent risk factor for existing cardiovascular disease, preceding a major cardiovascular event by an average of about 5 years. Are men prescribed a PDE5 inhibitor for ED more likely to have a new diagnosis of underlying medical conditions compared to men of a similar age not receiving PDE5 inhibitor treatment?'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a PDE5 inhibitor prescription and within the age-match control.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Records of men aged \\>18 years with an index PDE5 inhibitor (sildenafil, tadalafil or vardenafil) prescription between January 1st, 1999, and June 30th, 2008\n* no prior PDE5 inhibitor prescription before the index prescription\n* continuous enrolment with medical history for ≥60 months prior to the index prescription date\n\nExclusion Criteria:\n\n* Records of female subjects and any male subjects not meeting the inclusion criteria will be excluded\n* A subject can only be selected once independent of the assignment to the target or the control populations.'}, 'identificationModule': {'nctId': 'NCT01150903', 'briefTitle': 'Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Prevalence and Incidence of Underlying Disease Diagnosed in Men With Erectile Dysfunction When Prescribed a PDE5i for the First Time', 'orgStudyIdInfo': {'id': 'A1481287'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PDE5 inhibitor prescription', 'interventionNames': ['Other: no intervention']}, {'label': 'Age-matched Control', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'non-interventional study', 'armGroupLabels': ['PDE5 inhibitor prescription']}, {'name': 'no intervention', 'type': 'OTHER', 'description': 'non-interventional study', 'armGroupLabels': ['Age-matched Control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}