Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor
NCT01150903
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Records of men aged >18 years with an index PDE5 inhibitor (sildenafil, tadalafil or vardenafil) prescription between January 1st, 1999, and June 30th, 2008
- no prior PDE5 inhibitor prescription before the index prescription
- continuous enrolment with medical history for ≥60 months prior to the index prescription date
- Records of female subjects and any male subjects not meeting the inclusion criteria
will be excluded
- A subject can only be selected once independent of the assignment to the target or the
control populations.
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Descriptive Information | ||||
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Brief Title | Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor | |||
Official Title | Prevalence and Incidence of Underlying Disease Diagnosed in Men With Erectile Dysfunction When Prescribed a PDE5i for the First Time | |||
Brief Summary | 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? | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Patients with a PDE5 inhibitor prescription and within the age-match control. | |||
Condition |
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Intervention | Other: no intervention
non-interventional study | |||
Study Groups/Cohorts |
| |||
Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 98832 | |||
Original Estimated Enrollment | 50000 | |||
Actual Study Completion Date | August 2010 | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01150903 | |||
Other Study ID Numbers | A1481287 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | April 2012 |