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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDE5 inhibitor prescription |
| ||
| Age-matched Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | non-interventional study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription | 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. | Day -92 up to Day -1 of index prescription |
| Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91 | 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. | Day 0 to Day 91 post index prescription |
| Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription | 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. | Day -92 up to Day -1 of index prescription |
| Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription | 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. | Day 366 up to Day 457 post index prescription |
| Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a PDE5 inhibitor prescription and within the age-match control.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21676121 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Index PDE5i Prescription | 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). |
| FG001 | Control (Without PDE5i Prescription) | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Index PDE5i Prescription | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription | 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. | 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. | Posted | Number | Percentage of participants | Day -92 up to Day -1 of index prescription |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Index PDE5i Prescription | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D002318 | Cardiovascular Diseases |
| D052801 | Male Urogenital Diseases |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| no intervention |
| Other |
non-interventional study |
|
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. |
| Up to 3 years (Early study period - January 1999 to December 2001) |
| Up to 3 years (Early study period - January 1999 to December 2001) |
| Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period | 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. | Up to 2 years (End of study period - July 2006 to June 2008) |
| Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period | 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. | Up to 2 years (End of study period - July 2006 to June 2008) |
| Control (Without PDE5i Prescription) |
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). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Continuous | Median | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Control (Without PDE5i Prescription) | 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). |
|
|
|
| Primary | Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91 | 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. | 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. | Posted | Number | Percentage of participants | Day 0 to Day 91 post index prescription |
|
|
|
|
| Primary | Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription | 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. | 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. | Posted | Number | Percentage of participants | Day -92 up to Day -1 of index prescription |
|
|
|
| Primary | Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription | 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. | 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. | Posted | Number | Percentage of participants | Day 366 up to Day 457 post index prescription |
|
|
|
| Primary | Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period | 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. | 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. | Posted | Number | Percentage of participants | Up to 3 years (Early study period - January 1999 to December 2001) |
|
|
|
| Secondary | Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period | 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. | 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. | Posted | Number | Percentage of participants | Up to 3 years (Early study period - January 1999 to December 2001) |
|
|
|
| Secondary | Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period | 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. | 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. | Posted | Number | Percentage of participants | Up to 2 years (End of study period - July 2006 to June 2008) |
|
|
|
| Secondary | Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period | 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. | 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. | Posted | Number | Percentage of participants | Up to 2 years (End of study period - July 2006 to June 2008) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control (Without PDE5i Prescription) | 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). | 0 | 0 | 0 | 0 |
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.
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |